The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
ROSY-O is an open label, non-randomised, multicentre,international trial for patients who have completed a parent study using olaparib and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
185
300 mg olaparib (2×150 mg tablets) twice daily
Safety follow up
Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.
Time frame: Baseline up to approximately 10 years
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