Status:
ACTIVE_NOT_RECRUITING
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetic Laboratories, Inc.
Conditions:
Platinum Sensitive
BRCA Mutated
Eligibility:
FEMALE
18-130 years
Phase:
PHASE3
Brief Summary
A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (...
Detailed Description
Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which...
Eligibility Criteria
Inclusion
- Patients must be ≥ 18 years of age.
- Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer.
- Documented mutation in BRCA1 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 received at least 2 previous lines of platinum containing therapy prior to randomisation
- For the penultimate chemotherapy course prior to enrolment on the study:
- • Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy
- For the last chemotherapy course immediately prior to randomisation on the study:
- Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course
- Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin) and have received at least 4 cycles of treatment
- Patients must be randomized within 8 weeks of their last dose of chemotherapy
- Maintenance treatment is allowed at the end of the penultimate platinum regimen, including bevacizumab
Exclusion
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental (e.g., "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism" etc.)
- Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
Key Trial Info
Start Date :
September 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT01874353
Start Date
September 3 2013
End Date
December 31 2025
Last Update
August 3 2025
Active Locations (126)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Palo Alto Foundation Medical Group
San Francisco, California, United States
3
University of Colorado
Aurora, Colorado, United States
4
The Hospital of Central Connecticut
New Britain, Connecticut, United States