Relapsed Ovarian Cancer, BRCA Mutation, Platinum SensitivityPhase 2NCT02983799

Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

A Phase 2 study testing OLAPARIB in people with Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity, run by AstraZeneca at 47 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer. Read more about this study

Who is it for?: Ages 18 to 130 years, women only
Conditions the study is for: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
What is being tested?: OLAPARIB
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 272 participants
Where: 47 sitesin 2 countries
Study dates: 22 Dec 2016to 3 Dec 2020
Phase: Phase 2
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 to 130 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of written signed informed consent prior to any study specific procedures;
Female subjects with histologically diagnosed relapsed high-grade serous or high-grade endometrioid ovarian cancer;
At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment;
Subjects must have received at least 1 prior platinum-based line of chemotherapy for ovarian cancer. Note: There is no limit on the number of lines of chemotherapy;
Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy);
Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment;

Show all 11Show fewer

ECOG performance status 0 to 1;
Subjects must have a life expectancy greater than or equal to 16 weeks;
Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1;
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations; and
Formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from the primary or recurrent cancer must be available for central testing. If there is not written confirmation of the availability of an archived or fresh tumor sample prior to enrollment, the subject is not eligible for the study.

Who cannot join

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca Representative staff and/or staff at the study site);
Previous enrollment in the present study;
Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment;
Any previous treatment with a PARP inhibitor, including olaparib;
Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
Other malignancy within the last 5 years (few exceptions apply);

Show all 19Show fewer

Resting ECG with clinically significant abnormal findings;
Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors;
Concomitant use of known strong or moderate CYP3A inducers;
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia;
Subjects with MDS/AML or with features suggestive of MDS/AML;
Subjects with pneumonitis or at risk of pneumonitis;
Subjects with symptomatic uncontrolled brain metastases;
Major surgery within 2 weeks of starting study treatment, and subjects must have recovered from any effects of any major surgery;
Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection;
Breast feeding women;
Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus;
Subjects with known active hepatitis (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids

Trial locations and contacts

47 sites in 2 countries.

Country

City, postcode or hospital

47 sites in 2 countries

United States35 sites

Research Site
Abington, Pennsylvania, 19001
Research Site
Anchorage, Alaska, 99508
Research Site
Annandale, Virginia, 22003
Research Site
Aurora, Colorado, 80045
Research Site
Berkeley Heights, New Jersey, 07922
Research Site
Cincinnati, Ohio, 45219
Research Site
Detroit, Michigan, 48201
Research Site
Detroit, Michigan, 48202
Research Site
Germantown, Tennessee, 38138
Research Site
Hackensack, New Jersey, 07601
Research Site
Hartford, Connecticut, 06102
Research Site
Houston, Texas, 77030
Research Site
La Jolla, California, 92093
Research Site
Los Angeles, California, 90017
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Minneapolis, Minnesota, 55407
Research Site
New Haven, Connecticut, 06519
Research Site
New York, New York, 10021
Research Site
New York, New York, 10032
Research Site
New York, New York, 10065
Research Site
Newark, Delaware, 19718
Research Site
Newark, New Jersey, 07103
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Pittsburgh, Pennsylvania, 15224
Research Site
Portland, Oregon, 97227
Research Site
Providence, Rhode Island, 02905
Research Site
Saint Paul, Minnesota, 55125
Research Site
Shreveport, Louisiana, 71103
Research Site
Silver Spring, Maryland, 20910
Research Site
Skokie, Illinois, 60077
Research Site
South Miami, Florida, 33143
Research Site
Springfield, Massachusetts, 01199
Research Site
Teaneck, New Jersey, 07666
Research Site
The Bronx, New York, 10461
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada12 sites

Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Halifax, Nova Scotia, B3H 1V7
Research Site
Hamilton, Ontario, L8V 5C2
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Mississauga, Ontario, L5M 2N1
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H2X 0A9
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Vancouver, British Columbia, VSZ 4E6
Research Site
Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy

Read the detailed description

This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of olaparib tablets 300 mg (two 150 mg tablets) given orally twice daily (bid) in subjects with platinum-sensitive or partially platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received at least 1 prior line of platinum-based chemotherapy.

The study will assess the effectiveness of olaparib tablets as measured by the objective response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, in subjects with germline BRCA mutations (gBRCAm), somatic BRCA mutations (sBRCAm), or potential aberrations in homologous recombination deficiency (HRD) as determined by myChoice® HRD, as well as in subjects without identifiable HRD. This study will utilize Myriad BRACAnalysis CDx® for germline BRCA analysis and a tumor test (myChoice® HRD) for tumor BRCA analysis and HRD status. Four cohorts will be identified based upon the genetic testing described above:

Cohort 1: gBRCAm,
Cohort 2: sBRCAm and germline BRCA wild type,
Cohort 3: myChoice® HRD positive (genomic instability positive) and BRCA wild type (BRCAwt) (no BRCA mutation),
Cohort 4: myChoice® HRD negative (genomic instability negative) and BRCAwt (no BRCA mutation).

Conditions: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
Being tested: OLAPARIB
Keywords: BRCA, ovarian, platinum, chemotherapy
Medical subject headings: Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OLAPARIBDrug
300 mg olaparib tablets taken orally twice daily

Study groups in NCT02983799
Study group	Role	What they receive
gBRCAm;	Experimental	germline BRCA mutant Receives: Drug: OLAPARIB
sBRCAm and germline BRCA wild type;	Experimental	somatic BRCA mutant, germline BRCA wild type Receives: Drug: OLAPARIB
myChoice® HRD positive and BRCAwt;	Experimental	genomic instability positive and no BRCA mutation Receives: Drug: OLAPARIB
myChoice® HRD negative and BRCAwt	Experimental	genomic instability negative and no BRCA mutation Receives: Drug: OLAPARIB

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)
Measured: From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)

Secondary outcomes (7)

Duration of Response, for Those Subjects With a Confirmed Response of CR or PR
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using duration of response
Measured: From the date of the measurement criteria for CR or PR are first met until the date of documented progression or death in the absence of disease progression (up to 36 months)
CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using CA-125 response rate
Measured: From baseline to Day 1 of each cycle and end of study treatment visit (up to 36 months)
Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using disease control rate (DCR). DCR is defined as the percentage of subjects with a best overall response of CR or PR (at any time up to and including the defined analysis cut-off point) or who have demonstrated stable disease (SD) for at least 8 weeks from first dose, divided by the number of subjects in the efficacy analysis set.
Measured: From first dose up until progression, or last evaluable assessment in the absence of progression
Progression Free Survival
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using progression free survival
Measured: From first dose to earlier date of assessment of objective progression or death by any cause in the absence of progression (up to 36 months)
Time to Any Progression
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using time to any progression
Measured: From first dose to earlier date of CA-125 progression or RECIST v1.1 progression, or death by any cause in absence of progression (up to 36 months)
Overall Survival
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using overall survival
Measured: From date of first dose to date of death from any cause (up to 48 months)
HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using HRRm gene panel status related to clinical outcome
Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 20163 Dec 2020

First posted6 Dec 2016 (estimated)
Study start22 Dec 2016
Primary completion3 Dec 2020
Study completion3 Dec 2020

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 (1)Papers the sponsor has linked to this study.
Other trials for Relapsed Ovarian Cancer, BRCA Mutation, Platinum SensitivityStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02983799
Sponsor's protocol ID: D0816L00003
Status last verified: Mar 2022
First submitted: 4 Nov 2016
Last updated: 13 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Expanded access: Available

Publications

Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5.
PubMed 39695768

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Platinum Sensitive, BRCA Mutated

All Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy
ClinicalTrials.gov ID: NCT02983799
Acronym / sponsor ID: D0816L00003
Conditions: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
Keywords: BRCA, ovarian, platinum, chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 272 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 22 Dec 2016 (actual)
Primary completion: 3 Dec 2020 (actual)
Study completion: 3 Dec 2020 (actual)
First posted: 6 Dec 2016 (estimated)
Results: Posted 13 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Cohort 1: gBRCAm,
Cohort 2: sBRCAm and germline BRCA wild type,
Cohort 3: myChoice® HRD positive (genomic instability positive) and BRCA wild type (BRCAwt) (no BRCA mutation),
Cohort 4: myChoice® HRD negative (genomic instability negative) and BRCAwt (no BRCA mutation).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
gBRCAm;	Experimental	Drug: OLAPARIBgermline BRCA mutant
sBRCAm and germline BRCA wild type;	Experimental	Drug: OLAPARIBsomatic BRCA mutant, germline BRCA wild type
myChoice® HRD positive and BRCAwt;	Experimental	Drug: OLAPARIBgenomic instability positive and no BRCA mutation
myChoice® HRD negative and BRCAwt	Experimental	Drug: OLAPARIBgenomic instability negative and no BRCA mutation

Who may qualify

Ages: 18 to 130 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Provision of written signed informed consent prior to any study specific procedures;
Female subjects with histologically diagnosed relapsed high-grade serous or high-grade endometrioid ovarian cancer;
At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment;
Subjects must have received at least 1 prior platinum-based line of chemotherapy for ovarian cancer. Note: There is no limit on the number of lines of chemotherapy;
Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy);

Key exclusion criteria (19 listed)

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca Representative staff and/or staff at the study site);
Previous enrollment in the present study;
Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment;
Any previous treatment with a PARP inhibitor, including olaparib;
Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;

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
OLAPARIB300 mg olaparib tablets taken orally twice daily	Drug	gBRCAm;, myChoice® HRD negative and BRCAwt, myChoice® HRD positive and BRCAwt;, sBRCAm and germline BRCA wild type;

Primary outcome

Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
Time frame: From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)
To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)

7 secondary outcomes

Duration of Response, for Those Subjects With a Confirmed Response of CR or PR
Time frame: From the date of the measurement criteria for CR or PR are first met until the date of documented progression or death in the absence of disease progression (up to 36 months)
CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response
Time frame: From baseline to Day 1 of each cycle and end of study treatment visit (up to 36 months)
Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event
Time frame: From first dose up until progression, or last evaluable assessment in the absence of progression
Progression Free Survival
Time frame: From first dose to earlier date of assessment of objective progression or death by any cause in the absence of progression (up to 36 months)
Time to Any Progression
Time frame: From first dose to earlier date of CA-125 progression or RECIST v1.1 progression, or death by any cause in absence of progression (up to 36 months)
Overall Survival
Time frame: From date of first dose to date of death from any cause (up to 48 months)
HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)
Time frame: At baseline

Results and safety

Results posted to the registry on 13 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COHORT 1	75	25
COHORT 2	26	8
COHORT 3	68	18
COHORT 4	90	14
Unassigned	13	3

Primary outcome: Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)

Time frame: From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months). Number (95% Confidence Interval). Unit: Percent

Measure	Cohort 1 n = 75	Cohort 2 n = 25	COHORT 3 n = 68	COHORT 4 n = 89	Unassigned n = 13
Value	69.3 (57.6 to 79.5)	64.0 (42.5 to 82.0)	29.4 (19.0 to 41.7)	10.1 (4.7 to 18.3)	30.8 (9.1 to 61.4)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs), serious AEs, AEs of special interest (AESIs), and AEs leading to discontinuation were collected from signature of informed consent for study participation. Treatment emerging AEs were reported from date of first dose of study treatment and continued throughout the active treatment period and the follow-up period 30 days after the last dose of olaparib. After the primary analysis data cut-off till study completion, only deaths, SAEs, AESIs and DAEs were collected/reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COHORT 1	13 of 75 (17.3%)	75 of 75 (100%)	20 of 75
COHORT 2	8 of 25 (32%)	25 of 25 (100%)	5 of 25
COHORT 3	7 of 68 (10.3%)	67 of 68 (98.5%)	23 of 68
COHORT 4	35 of 90 (38.9%)	88 of 90 (97.8%)	47 of 90
UNASSIGNED	6 of 13 (46.2%)	12 of 13 (92.3%)	7 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39695768Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Related trials for Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Active, not recruitingPhase 3
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Platinum Sensitive, BRCA Mutated

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.

The record lists no contact. Use the official record to reach the sponsor.

47 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OLAPARIB in people with Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity, run by AstraZeneca at 47 sites in 2 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 11 inclusion and 19 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 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Apr 2022). 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?

Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) (time frame: From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)). 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 NCT02983799, which also lists 1 linked publication.

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 13 Apr 2022.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (11 listed)

Key exclusion criteria (19 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)

Adverse events

Research links

Related trials for Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)

Adverse events