BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Conditions
Interventions
investigational material(s)
Generic name etc : Olaparib 300mg tablets
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
AstraZeneca
European Network of Gynecological Oncology Trial Groups (ENGOT)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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.
Outcome results
None listed