Phase 3 Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
- Conditions
- BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
- Registration Number
- JPRN-jRCT2080222310
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- Not specified
Patients must be 18 years of age or more.
>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).
>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:
-Patients 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
-Patients must have received a platinum based chemotherapy regimen (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
-Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
-BRCA1 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method