Ovarian NeoplasmsPhase 3NCT01847274
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
A Phase 3 study testing Active comparator: Niraparib in people with Ovarian Neoplasms and Platinum Sensitive Ovarian Cancer, run by Tesaro, Inc. at 112 sites in 15 countries.
Trial summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Platinum Sensitive Ovarian Cancer
- What is being tested?
- Active comparator: Niraparib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 596 participants
- Where
- 112 sitesin 15 countries
- Study dates
- 21 Jun 2013to 26 Dec 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older, female, any race
- Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- High grade (or grade 3) serous histology or known to have gBRCAmut
- Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
- Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
- ECOG 0-1
- Adequate bone marrow, kidney and liver function
Who cannot join
- Known hypersensitivity to the components of niraparib
- Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
- Symptomatic uncontrolled brain metastasis
- Is pregnant or breast feeding
- Immunocompromised patients
- Known active hepatic disease
- Prior treatment with a known PARP inhibitor
Trial locations and contacts
112 sites in 15 countries.
112 sites in 15 countries
United States35 sites
GSK Investigational Site
Abington, Pennsylvania, 19001-3788
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Austin, Texas, 78731
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Burlington, Massachusetts, 01805
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Dallas, Texas, 75390
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Farmington, New Mexico, 87401
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Indianapolis, Indiana, 46260
GSK Investigational Site
Lake Success, New York, 11042
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Minneapolis, Minnesota, 55404
GSK Investigational Site
Minneapolis, Minnesota, 55455
GSK Investigational Site
Morristown, New Jersey, 07962-1956
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
New Haven, Connecticut, 06510
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Palo Alto, California, 94304
GSK Investigational Site
Philadelphia, Pennsylvania, 19111
GSK Investigational Site
Phoenix, Arizona, 85013
GSK Investigational Site
Providence, Rhode Island, 02905
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
San Francisco, California, 94109
GSK Investigational Site
Sarasota, Florida, 34232
GSK Investigational Site
Tampa, Florida, 33612
GSK Investigational Site
The Woodlands, Texas, 77380
GSK Investigational Site
Tucson, Arizona, 85704
GSK Investigational Site
Vancouver, Oregon, 98684
Germany11 sites
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40217
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Essen, North Rhine-Westphalia, 45136
GSK Investigational Site
Göttingen, Lower Saxony, 37075
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Hanover, Lower Saxony, 30177
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105
GSK Investigational Site
Munich, Bavaria, 81377
United Kingdom11 sites
GSK Investigational Site
Bebington, Wirral, CH63 4JY
GSK Investigational Site
Birmingham, West Midlands, B18 7QH
GSK Investigational Site
London, NW1 2PG
GSK Investigational Site
London, SE1 9RT
GSK Investigational Site
London, SW3 6JJ
GSK Investigational Site
London, SW36JJ
GSK Investigational Site
Maidstone, ME16 9QQ
GSK Investigational Site
Nottingham, Nottinghamshire, NG5 1PB
GSK Investigational Site
Rhyl, LL18 5UJ
GSK Investigational Site
Taunton, TA1 5DA
GSK Investigational Site
Yeovil, Somerset, BA21 4AT
Canada8 sites
GSK Investigational Site
Calgary, Alberta, T2N 4N2
GSK Investigational Site
Kelowna, British Columbia, V1Y 5L3
GSK Investigational Site
Montreal, Quebec, H2L 4M1
GSK Investigational Site
Montreal, Quebec, H3T 1E2
GSK Investigational Site
Montreal, Quebec, H4A 3J1
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4
GSK Investigational Site
Toronto, Ontario, M5G 2M9
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E6
Israel8 sites
GSK Investigational Site
Haifa, 3109601
GSK Investigational Site
Holon, 58100
GSK Investigational Site
Jerusalem, 91031
GSK Investigational Site
Jerusalem, 91120
GSK Investigational Site
Kfar Saba, 44281
GSK Investigational Site
Rehovot, 76100
GSK Investigational Site
Tel Aviv, 64239
GSK Investigational Site
Tel Litwinsky, 52621
Spain7 sites
GSK Investigational Site
Barcelona, 08907
GSK Investigational Site
Barcelona, 8035
GSK Investigational Site
Madrid, 28033
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Oviedo, Principality of Asturias, 33011
GSK Investigational Site
Palma de Mallorca, 07198
France6 sites
GSK Investigational Site
Besançon, 25030
GSK Investigational Site
Lille, 59000
GSK Investigational Site
Montpellier, 34298
GSK Investigational Site
Nice, 06189
GSK Investigational Site
Saint-Brieuc, 22015 cedex
GSK Investigational Site
Saint-Herblain, 44805
Italy5 sites
GSK Investigational Site
Brescia, Lombardy, 25123
GSK Investigational Site
Catania, Sicily, 95126
GSK Investigational Site
Milan, Lombardy, 20141
GSK Investigational Site
Milan, 20133
GSK Investigational Site
Rome, Lazio, 00168
Belgium4 sites
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Kortrijk, 8500
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000
Denmark4 sites
GSK Investigational Site
Aalborg, 9100
GSK Investigational Site
Copenhagen, DK-2100
GSK Investigational Site
Herlev, DK-2730
GSK Investigational Site
Odense, 5000
Poland4 sites
GSK Investigational Site
Bialystok, 15-207
GSK Investigational Site
Gdansk, 80-219
GSK Investigational Site
Lodz, 94-029
GSK Investigational Site
Poznan, 60-569
Austria3 sites
GSK Investigational Site
Graz, A-8036
GSK Investigational Site
Innsbruck, A-6020
GSK Investigational Site
Vienna, 1090
Sweden3 sites
GSK Investigational Site
Linköping, SE-581 85
GSK Investigational Site
Lund, SE-221 85
GSK Investigational Site
Stockholm, SE-171 76
Norway2 sites
GSK Investigational Site
Bergen, 5021
GSK Investigational Site
Oslo, 0379
About this study
Official title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.
The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).
- Being tested
- Active comparator: Niraparib, placebo
- Keywords
- ovarian cancer, platinum sensitive, gBRCAmut, BRCA, high-grade serous histology, PARP inhibitor
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparator: NiraparibDrug
Also called Niraparib
Niraparib vs placebo 2:1 ratio
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Niraparib | Active comparator | 2:1 Ratio administered once daily continuously during a 28 day cycle. Receives: Drug: Active comparator: Niraparib |
| Placebo | Placebo comparator | Administered once daily continuously over a 28 day cycle. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Measured: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days
Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Measured: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Measured: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
Secondary outcomes (48)
Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.
Measured: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death
Measured: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment
Measured: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days
Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment
Measured: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days
Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.
Measured: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.
Measured: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
Overall survival was defined as the date of randomization to the date of death by any cause.
Measured: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Overall Survival in Cohort With No Germline BRCA Mutation
Overall survival was defined as the date of randomization to the date of death by any cause.
Measured: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
Measured: From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days
Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
Measured: From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression
Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression
EQ-5D-5L is a well-validated, general preference-based, health-related Quality of Life (QoL) instrument. The EQ-5D-5L encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Measured: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit"). Baseline was latest non-missing pre-dose assessment on or before randomization date.
Measured: At Baseline
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Measured: At Cycle 2 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Measured: At Cycle 4 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Measured: At Cycle 6 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Measured: Up to 7 years, 7 months and 4 days
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit"). Baseline was latest non-missing pre-dose assessment on or before randomization date.
Measured: At Baseline
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Measured: At Cycle 2 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Measured: At Cycle 4 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Measured: At Cycle 6 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression
A Neuropathy Questionnaire measures the participant's symptom experience over the past 7 days using a 5-point Likert scale of "not at all" (0) to "very much" (4). There are 2 items that ask if the participant's feet (item 1) or hands (item 2) feel numb or have prickling/tingling feelings. The Neuropathy Questionnaire was used to determine the chemotherapy-induced peripheral neuropathy (CIPN) status of each participant as well as provide an anchor for interpreting the impact of CIPN on participant's QoL. Two thresholds were used. For the first, a participant was determined to have CIPN if a score greater than 0 ("not at all") was recorded for either item. For the second, CIPN was assigned if a participant recorded a score greater than 1 ("a little bit").
Measured: Up to 7 years, 7 months and 4 days
Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study
This will never be analyzed since the data for the candidate companion BRAC analysis diagnostic test was not collected which was to be compared with centralized BRCA mutation test used in this study.
Measured: Up to 7 years, 7 months and 4 days
Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study
This will never be analyzed since the data for the candidate companion HRD diagnostic test was not collected which was to be compared with HRD test used in this study.
Measured: Up to 7 years, 7 months and 4 days
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. Data presented for this outcome measure is based on the data cut-off date of 31-March-2021, which aligns with the time of the study unblinding.
Measured: Up to 7 years, 7 months and 6 days
Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)
An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. The data is presented for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
Measured: Up to 8 months, 26 days
Number of Participants With Non-serious AEs and SAEs in FE Sub-study
An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events.
Measured: Up to 2 years, 3 months and 11 days
Number of Participants With Non-serious AEs and SAEs in QTc Sub-study
An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events.
Measured: Up to 5 years 10 months and 22 days
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze AUC(0-infinity) of niraparib.
Measured: Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-last]) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the AUC(0-last) of niraparib.
Measured: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the maximum observed plasma concentration of niraparib.
Measured: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the tmax of niraparib.
Measured: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)
Blood samples were collected at indicated time points to analyze the t1/2 of niraparib.
Measured: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds
12-lead electrocardiogram was obtained at indicated time points using an automated electrocardiogram machine that measured QTcF interval. The number of participants with maximum post-Baseline ECG value exceeding the following limits have been reported: QTcF interval >450 and <= 480 milliseconds (msec) and >500 msec.
Measured: At Baseline (Cycle 1 Day 1, each cycle was of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study start21 Jun 2013
- Primary completion22 Apr 2016
- Study completion26 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tesaro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetics, Inc., US Oncology Research, Sarah Cannon, Cooperative Ovarian Cancer Group (COGI), Facing Our Risk of Cancer Empowered
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Studies, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847274
- Sponsor's protocol ID
- 213356
- Other IDs
- PR-30-5011-C
- Status last verified
- May 2023
- First submitted
- 11 Apr 2013
- Last updated
- 2 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7.
PubMed 27717299Mirza MR, Lindahl G, Mahner S, Redondo A, Fabbro M, Rimel BJ, Herrstedt J, Oza AM, Canzler U, Berek JS, Gonzalez-Martin A, Follana P, Lord R, Azodi M, Estenson K, Wang Z, Li Y, Gupta D, Matulonis U, Feng B. Ad hoc Analysis of the Phase III ENGOT-OV16/NOVA Study: Niraparib Efficacy in Germline BRCA Wild-type Recurrent Ovarian Cancer with Homologous Recombination Repair Defects. Cancer Res Commun. 2022 Nov 15;2(11):1436-1444. doi: 10.1158/2767-9764.CRC-22-0240. eCollection 2022 Nov.
PubMed 36970052Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AO, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, Gonzalez-Martin A. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer. Clin Ther. 2024 Aug;46(8):612-621. doi: 10.1016/j.clinthera.2024.06.001. Epub 2024 Jul 16.
PubMed 39019698Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
PubMed 35170751Mirza MR, Benigno B, Dorum A, Mahner S, Bessette P, Barcelo IB, Berton-Rigaud D, Ledermann JA, Rimel BJ, Herrstedt J, Lau S, du Bois A, Herraez AC, Kalbacher E, Buscema J, Lorusso D, Vergote I, Levy T, Wang P, de Jong FA, Gupta D, Matulonis UA. Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial. Gynecol Oncol. 2020 Nov;159(2):442-448. doi: 10.1016/j.ygyno.2020.09.006. Epub 2020 Sep 25.
PubMed 32981695Matulonis UA, Walder L, Nottrup TJ, Bessette P, Mahner S, Gil-Martin M, Kalbacher E, Ledermann JA, Wenham RM, Woie K, Lau S, Marme F, Casado Herraez A, Hardy-Bessard AC, Banerjee S, Lindahl G, Benigno B, Buscema J, Travers K, Guy H, Mirza MR. Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Dec 1;37(34):3183-3191. doi: 10.1200/JCO.19.00917. Epub 2019 Sep 16.
PubMed 31518175Del Campo JM, Matulonis UA, Malander S, Provencher D, Mahner S, Follana P, Waters J, Berek JS, Woie K, Oza AM, Canzler U, Gil-Martin M, Lesoin A, Monk BJ, Lund B, Gilbert L, Wenham RM, Benigno B, Arora S, Hazard SJ, Mirza MR. Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Nov 10;37(32):2968-2973. doi: 10.1200/JCO.18.02238. Epub 2019 Jun 7.
PubMed 31173551Oza AM, Matulonis UA, Malander S, Hudgens S, Sehouli J, Del Campo JM, Berton-Rigaud D, Banerjee S, Scambia G, Berek JS, Lund B, Tinker AV, Hilpert F, Vazquez IP, D'Hondt V, Benigno B, Provencher D, Buscema J, Agarwal S, Mirza MR. Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2018 Aug;19(8):1117-1125. doi: 10.1016/S1470-2045(18)30333-4. Epub 2018 Jul 17.
PubMed 30026000Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181.
PubMed 29767688
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT01847274
- Acronym / sponsor ID
- 213356
- Keywords
- ovarian cancer, platinum sensitive, gBRCAmut, BRCA, high-grade serous histology, PARP inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Tesaro, Inc.Industry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetics, Inc., US Oncology Research, Sarah Cannon, Cooperative Ovarian Cancer Group (COGI), Facing Our Risk of Cancer Empowered
- Study start
- 21 Jun 2013 (actual)
- Primary completion
- 22 Apr 2016 (actual)
- Study completion
- 26 Dec 2021 (actual)
- First posted
- 6 May 2013 (estimated)
- Results
- Posted 1 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.
The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niraparib | Active comparator | Drug: Active comparator: Niraparib2:1 Ratio administered once daily continuously during a 28 day cycle. |
| Placebo | Placebo comparator | Drug: placeboAdministered once daily continuously over a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older, female, any race
- Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- High grade (or grade 3) serous histology or known to have gBRCAmut
- Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
- Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
Key exclusion criteria (7 listed)
- Known hypersensitivity to the components of niraparib
- Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
- Symptomatic uncontrolled brain metastasis
- Is pregnant or breast feeding
- Immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active comparator: NiraparibAlso: NiraparibNiraparib vs placebo 2:1 ratio | Drug | Niraparib |
| placebo | Drug | Placebo |
Primary outcome
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
Time frame: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
Time frame: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
Time frame: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
48 secondary outcomes
Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
Time frame: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
Time frame: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
Time frame: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days
Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
Time frame: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days
Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
Time frame: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
Time frame: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
Time frame: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Overall Survival in Cohort With No Germline BRCA Mutation
Time frame: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
Time frame: From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days
Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
Time frame: From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
Time frame: Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
Time frame: Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression
Time frame: Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression
Time frame: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression
Time frame: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6
Time frame: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression
Time frame: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
Time frame: At Baseline
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2
Time frame: At Cycle 2 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4
Time frame: At Cycle 4 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
Time frame: At Cycle 6 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression
Time frame: Up to 7 years, 7 months and 4 days
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline
Time frame: At Baseline
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2
Time frame: At Cycle 2 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4
Time frame: At Cycle 4 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6
Time frame: At Cycle 6 (Each cycle was of 28 days)
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression
Time frame: Up to 7 years, 7 months and 4 days
Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study
Time frame: Up to 7 years, 7 months and 4 days
Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study
Time frame: Up to 7 years, 7 months and 4 days
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Up to 7 years, 7 months and 6 days
Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)
Time frame: Up to 8 months, 26 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27717299Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7.
- Background: PubMed 36970052Mirza MR, Lindahl G, Mahner S, Redondo A, Fabbro M, Rimel BJ, Herrstedt J, Oza AM, Canzler U, Berek JS, Gonzalez-Martin A, Follana P, Lord R, Azodi M, Estenson K, Wang Z, Li Y, Gupta D, Matulonis U, Feng B. Ad hoc Analysis of the Phase III ENGOT-OV16/NOVA Study: Niraparib Efficacy in Germline BRCA Wild-type Recurrent Ovarian Cancer with Homologous Recombination Repair Defects. Cancer Res Commun. 2022 Nov 15;2(11):1436-1444. doi: 10.1158/2767-9764.CRC-22-0240. eCollection 2022 Nov.
- Derived from this study: PubMed 39019698Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AO, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, Gonzalez-Martin A. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer. Clin Ther. 2024 Aug;46(8):612-621. doi: 10.1016/j.clinthera.2024.06.001. Epub 2024 Jul 16.
- Derived from this study: PubMed 35170751Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
- Derived from this study: PubMed 32981695Mirza MR, Benigno B, Dorum A, Mahner S, Bessette P, Barcelo IB, Berton-Rigaud D, Ledermann JA, Rimel BJ, Herrstedt J, Lau S, du Bois A, Herraez AC, Kalbacher E, Buscema J, Lorusso D, Vergote I, Levy T, Wang P, de Jong FA, Gupta D, Matulonis UA. Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial. Gynecol Oncol. 2020 Nov;159(2):442-448. doi: 10.1016/j.ygyno.2020.09.006. Epub 2020 Sep 25.
- Derived from this study: PubMed 31518175Matulonis UA, Walder L, Nottrup TJ, Bessette P, Mahner S, Gil-Martin M, Kalbacher E, Ledermann JA, Wenham RM, Woie K, Lau S, Marme F, Casado Herraez A, Hardy-Bessard AC, Banerjee S, Lindahl G, Benigno B, Buscema J, Travers K, Guy H, Mirza MR. Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Dec 1;37(34):3183-3191. doi: 10.1200/JCO.19.00917. Epub 2019 Sep 16.
- Derived from this study: PubMed 31173551Del Campo JM, Matulonis UA, Malander S, Provencher D, Mahner S, Follana P, Waters J, Berek JS, Woie K, Oza AM, Canzler U, Gil-Martin M, Lesoin A, Monk BJ, Lund B, Gilbert L, Wenham RM, Benigno B, Arora S, Hazard SJ, Mirza MR. Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Nov 10;37(32):2968-2973. doi: 10.1200/JCO.18.02238. Epub 2019 Jun 7.
- Derived from this study: PubMed 30026000Oza AM, Matulonis UA, Malander S, Hudgens S, Sehouli J, Del Campo JM, Berton-Rigaud D, Banerjee S, Scambia G, Berek JS, Lund B, Tinker AV, Hilpert F, Vazquez IP, D'Hondt V, Benigno B, Provencher D, Buscema J, Agarwal S, Mirza MR. Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2018 Aug;19(8):1117-1125. doi: 10.1016/S1470-2045(18)30333-4. Epub 2018 Jul 17.
- Derived from this study: PubMed 29767688Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181.
- Facing our risk of cancer empowered websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Studies study director
GlaxoSmithKline
112 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active comparator: Niraparib in people with Ovarian Neoplasms and Platinum Sensitive Ovarian Cancer, run by Tesaro, Inc. at 112 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in United States, Germany, United Kingdom, Canada, Israel and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (time frame: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01847274, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.