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Sponsor: AstraZeneca
Conditions: Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy
Interventions: Olaparib 300mg tablets, Placebo to match olaparib 300mg
Countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany
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 (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (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 responded following platinum based chemotherapy.
Sex: FEMALE
Age: 18 Years to 130 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Criteria: * 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.
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Britain, Connecticut, United States
- Orlando, Florida, United States
- Evanston, Illinois, United States
- Baltimore, Maryland, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
- Voorhees Township, New Jersey, United States
- Albany, New York, United States
- Mineola, New York, United States
- Hilliard, Ohio, United States
- Nashville, Tennessee, United States
- Milwaukee, Wisconsin, United States
- Heidelberg, Australia
- Parkville, Australia
- Randwick, Australia
- Ghent, Belgium
- Leuven, Belgium
- Barretos, Brazil
- Fortaleza, Brazil
- Goiânia, Brazil
- Ijuí, Brazil
- Itajaí, Brazil
- Porto Alegre, Brazil
- Porto Alegre, Brazil
- São José do Rio Preto, Brazil
- São Paulo, Brazil
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