Platinum Sensitive Relapsed Ovarian CancerPhase 3NCT02392676
Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations
A Phase 3 study testing OLAPARIB in people with Platinum Sensitive Relapsed Ovarian Cancer, run by AstraZeneca at 29 sites in 5 countries.
Trial summary
Olaparib administered as monotherapy in the maintenance setting improves progression free survival compared to placebo in patients whose tumours carry loss of function (deleterious or suspected deleterious) somatic BRCA mutations or loss of function (deleterious or suspected deleterious) mutation in non-BRCA… Read more about this study
- Who is it for?
- Ages 18 to 96 years, women only
- Conditions the study is for
- Platinum Sensitive Relapsed Ovarian Cancer
- What is being tested?
- OLAPARIB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 29 sitesin 5 countries
- Study dates
- Jul 2016to Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 96 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 18 years of age
- Histologically diagnosed relapsed high grade epithelial ovarian cancer (including primary peritoneal and/ or fallopian tube cancer)
- Documented deleterious or suspected deleterious somatic BRCA 1 and/or BRCA 2 somatic mutation or evidence of non- BRCA HRR-associated gene mutation in the tumour.
- At least 2 previous lines of platinum containing therapy prior to randomisation.
- CA-125 measurements prior to randomised treatment
- Patients must have normal organ and bone marrow function measured within 28 days of randomisation
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
- Provision of a blood sample for cfDNA biomarker analysis in Pre-Screening Part 1
- Formalin fixed, paraffin embedded (FFPE) tumour sample from the primary or recurrent cancer must be available for central testing. If archival tumour sample is not available tumour sample from fresh biopsy is acceptable, for all patients eligible to participate in Pre-Screening part 2.
Who cannot join
- Documented germline mutation in BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
- Patients who have had drainage of their ascites from the final 2 cycles of their last chemotherapy regimen prior to randomisation on the study
- Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation
- Any previous treatment with a PARP inhibitor, including olaparib
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product
- Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply)
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- Patients receiving any systemic chemotherapy (including chemotherapy received as the most recent anticancer therapy) or radiotherapy (except for palliative reasons) within 3 weeks prior to study randomised treatment
- Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) CTCAE grade 2) caused by previous cancer therapy, excluding CTCAE grade 2 peripheral neuropathy
- Patients with myelodysplastic syndrome/acute myeloid leukaemia (t-AML) or with features suggestive of MDS/AML
- Patients with symptomatic uncontrolled brain metastases
- Major surgery within 2 weeks of starting study randomised treatment and patients must have recovered from any effects of any major surgery
- Patients considered a poor medical risk
Trial locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
United States15 sites
Research Site
Albany, New York
Research Site
Augusta, Georgia
Research Site
Baltimore, Maryland
Research Site
Covington, Louisiana
Research Site
Iowa City, Iowa
Research Site
Los Angeles, California
Research Site
Louisville, Kentucky
Research Site
Milwaukee, Wisconsin
Research Site
Mobile, Alabama
Research Site
Oklahoma City, Oklahoma
Research Site
Park Ridge, Illinois
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Scarborough, Maine
Research Site
Stanford, California
United Kingdom8 sites
Research Site
Birmingham
Research Site
Cambridge
Research Site
Coventry
Research Site
Edinburgh
Research Site
London
Research Site
Manchester
Research Site
Oxford
Research Site
Sutton
South Korea3 sites
Research Site
Goyang-si
Research Site
Seongnam-si
Research Site
Seoul
About this study
Official title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With Platinum Sensitive Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy and Whose Tumours Carry Loss of Function Somatic BRCA Mutation(s) or Loss of Function Mutation(s) in Tumour Homologous Recombination Repair -Associated Genes
Olaparib administered as monotherapy in the maintenance setting improves progression free survival compared to placebo in patients whose tumours carry loss of function (deleterious or suspected deleterious) somatic BRCA mutations or loss of function (deleterious or suspected deleterious) mutation in non-BRCA Homologous Recombination Repair (HRR) -associated genes who have a complete or partial response to platinum-based chemotherapy.
Read the detailed description
This is a phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade epithelial ovarian cancer patients (including patients with primary peritoneal and / or fallopian tube cancer) who have responded following platinum based chemotherapy. The study population will be enrolled as two separate cohorts that will enrol simultaneously. The confirmatory cohort will consist of patients who carry a somatic BRCA mutation (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious) which are detected in tumour material but absent from germline blood testing ; the exploratory cohort will include patients with a mutation (documented mutation predicted to be deleterious or suspected deleterious) in non BRCA HRR-associated genes which are detected in tumour material regardless of their germline status.
- Being tested
- OLAPARIB, PLACEBO
- Keywords
- Ovarian cancer, Platinum, Somatic BRCA mutation, Homologous recombination repair
- 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
Patients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
PLACEBODrug
Patients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
| Study group | Role | What they receive |
|---|---|---|
| 1/OLAPARIB | Experimental | olaparib 300 mg oral tablets; twice daily Receives: Drug: OLAPARIB |
| 2/PLACEBO | Placebo comparator | placebo matching olaparib 300 mg oral tablets; twice daily Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) using modified RECIST 1.1 in the cohort of patients with sBRCA ovarian cancer
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of progression free survival (PFS) using blinded independent central review (BICR)
Measured: From date of randomization until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 40 months
Secondary outcomes (9)
Progression Free Survival (PFS) using modified RECIST 1.1. in the Intent to Treat Population (ITT) consisting of all randomised patients with sBRCAm or HRR-associated gene mutations
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of progression free survival (PFS)using blinded independent central review (BICR)
Measured: From date of randomization until the date of first documented progression or date of death (by any cause, in the absence of disease progression), whichever came first, assessed up to 60 months
Overall Survival (OS) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of overall survival (OS)
Measured: From the date of randomisation until death due to any cause, assessed up to 60 months
Time from randomisation to first subsequent therapy or death (TFST) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of Time from randomisation to first subsequent therapy or death
Measured: From the date of randomisation to the earlier of first subsequent therapy start date, assessed up to 60 months
Trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in sBRCA and HRR associated gene mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy
To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL)
Measured: Administered at baseline, at day 29 then every 8 weeks (+/- 1 week) regardless of treatment discontinuation or disease progression, assessed up to 24 months
Plasma mutation status
To determine if p53, somatic BRCA and other HRR mutations are present in plasma prior to chemotherapy
Measured: cfDNA sample collected during pre-screening, assessed up to 40 months
Time to earliest progression by RECIST 1.1 or CA-125 or Death in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of Time to earliest progression by RECIST 1.1 or CA-125 or Death. Progression or recurrence based on serum CA-125 levels will be defined on the basis of a progressive serial elevation of serum CA-125
Measured: From randomisation to the earliest date of investigator assesed RECIST or CA-125 progression or death by any cause, assessed up to 60 months
Time from randomisation to second progression (PFS2) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of Time from randomisation to second progression
Measured: From the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PRS or death, assessed up to 60 months
Time from randomisation to second subsequent therapy or death (TSST) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of Time from randomisation to second subsequent therapy of death
Measured: From the date of randomisation to the earlier of the date of second subsequent chemotherapy start date or death date, assessed up to 60 months
Time from randomisation to study treatment discontinuation or death (TDT) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of Time from randomisation to study treatment discontinuation or death
Measured: From the date of randomisation to the earlier of the date of study treatment discontinuation or death, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJul 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: Study is unlikely to be feasible given the evolving ovarian cancer landscape and alternative studies have the potential to meet future clinical demand.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum Sensitive Relapsed Ovarian CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Myriad Genetic Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- Charlie Gourley, Prof., Principal investigator, University of EdinburghCarol Aghajanian, MD, Principal investigator, MSKCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392676
- Sponsor's protocol ID
- D0816C00009
- Status last verified
- Apr 2016
- First submitted
- 23 Feb 2015
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With Platinum Sensitive Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy and Whose Tumours Carry Loss of Function Somatic BRCA Mutation(s) or Loss of Function Mutation(s) in Tumour Homologous Recombination Repair -Associated Genes
- ClinicalTrials.gov ID
- NCT02392676
- Acronym / sponsor ID
- D0816C00009
- Keywords
- Ovarian cancer, Platinum, Somatic BRCA mutation, Homologous recombination repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is unlikely to be feasible given the evolving ovarian cancer landscape and alternative studies have the potential to meet future clinical demand.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Myriad Genetic Laboratories, Inc.
- Study start
- Jul 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Olaparib administered as monotherapy in the maintenance setting improves progression free survival compared to placebo in patients whose tumours carry loss of function (deleterious or suspected deleterious) somatic BRCA mutations or loss of function (deleterious or suspected deleterious) mutation in non-BRCA Homologous Recombination Repair (HRR) -associated genes who have a complete or partial response to platinum-based chemotherapy.
Detailed description
This is a phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade epithelial ovarian cancer patients (including patients with primary peritoneal and / or fallopian tube cancer) who have responded following platinum based chemotherapy. The study population will be enrolled as two separate cohorts that will enrol simultaneously. The confirmatory cohort will consist of patients who carry a somatic BRCA mutation (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious) which are detected in tumour material but absent from germline blood testing ; the exploratory cohort will include patients with a mutation (documented mutation predicted to be deleterious or suspected deleterious) in non BRCA HRR-associated genes which are detected in tumour material regardless of their germline status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/OLAPARIB | Experimental | Drug: OLAPARIBolaparib 300 mg oral tablets; twice daily |
| 2/PLACEBO | Placebo comparator | Drug: PLACEBOplacebo matching olaparib 300 mg oral tablets; twice daily |
Who may qualify
- Ages
- 18 to 96 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must be ≥ 18 years of age
- Histologically diagnosed relapsed high grade epithelial ovarian cancer (including primary peritoneal and/ or fallopian tube cancer)
- Documented deleterious or suspected deleterious somatic BRCA 1 and/or BRCA 2 somatic mutation or evidence of non- BRCA HRR-associated gene mutation in the tumour.
- At least 2 previous lines of platinum containing therapy prior to randomisation.
- CA-125 measurements prior to randomised treatment
Key exclusion criteria (12 listed)
- Documented germline mutation in BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
- Patients who have had drainage of their ascites from the final 2 cycles of their last chemotherapy regimen prior to randomisation on the study
- Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation
- Any previous treatment with a PARP inhibitor, including olaparib
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product
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 |
|---|---|---|
| OLAPARIBPatients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria | Drug | 1/OLAPARIB |
| PLACEBOPatients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria | Drug | 2/PLACEBO |
Primary outcome
Progression Free Survival (PFS) using modified RECIST 1.1 in the cohort of patients with sBRCA ovarian cancer
Time frame: From date of randomization until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 40 months
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by assessment of progression free survival (PFS) using blinded independent central review (BICR)
9 secondary outcomes
Progression Free Survival (PFS) using modified RECIST 1.1. in the Intent to Treat Population (ITT) consisting of all randomised patients with sBRCAm or HRR-associated gene mutations
Time frame: From date of randomization until the date of first documented progression or date of death (by any cause, in the absence of disease progression), whichever came first, assessed up to 60 months
Overall Survival (OS) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
Time frame: From the date of randomisation until death due to any cause, assessed up to 60 months
Time from randomisation to first subsequent therapy or death (TFST) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
Time frame: From the date of randomisation to the earlier of first subsequent therapy start date, assessed up to 60 months
Trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in sBRCA and HRR associated gene mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy
Time frame: Administered at baseline, at day 29 then every 8 weeks (+/- 1 week) regardless of treatment discontinuation or disease progression, assessed up to 24 months
Plasma mutation status
Time frame: cfDNA sample collected during pre-screening, assessed up to 40 months
Time to earliest progression by RECIST 1.1 or CA-125 or Death in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
Time frame: From randomisation to the earliest date of investigator assesed RECIST or CA-125 progression or death by any cause, assessed up to 60 months
Time from randomisation to second progression (PFS2) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
Time frame: From the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PRS or death, assessed up to 60 months
Time from randomisation to second subsequent therapy or death (TSST) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
Time frame: From the date of randomisation to the earlier of the date of second subsequent chemotherapy start date or death date, assessed up to 60 months
Time from randomisation to study treatment discontinuation or death (TDT) in patients with sBRCAm ovarian cancer and in the ITT population consisting of all randomised patients
Time frame: From the date of randomisation to the earlier of the date of study treatment discontinuation or death, assessed up to 60 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
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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.
Charlie Gourley, Prof. principal investigator
University of Edinburgh
Carol Aghajanian, MD principal investigator
MSKCC
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OLAPARIB in people with Platinum Sensitive Relapsed Ovarian Cancer, run by AstraZeneca at 29 sites in 5 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 12 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: withdrawn, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, United Kingdom, South Korea, Peru, Philippines. 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?
The study was withdrawn before enrolling participants, so there are no results.
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) using modified RECIST 1.1 in the cohort of patients with sBRCA ovarian cancer (time frame: From date of randomization until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2016.