Note: This study is also known as the SOLO2 Study
Full study details on clinicaltrials.gov
Name of PARP Inhibitor used in study:
- 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
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.
Type of study:
Randomized Phase III
- Patients will be randomized to one of two arms:
- Olaparib 300 mg oral capsules twice daily
To get more information about the study sites recruiting patients, contact:
Elizabeth Lowe: ClinicalTrialTransparency@astrazeneca.com
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Paris Cedex 5
Pierre Benite Cedex
Vandoeuvre Les Nancy
Page updated 03/05/14