Study identifier:D0817C00098
ClinicalTrials.gov identifier:NCT04421963
EudraCT identifier:2019-003777-26
CTIS identifier:2024-512982-15-00
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
ovarian cancer
Phase 3
No
Olaparib
All
267
Interventional
18 Years - 99 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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
Location
Location
Montreal, QC, Canada, H2X 0A9
Location
Toronto, ON, Canada, M4N 3M5
Location
Montreal, QC, Canada, H4A-3J1
Location
Halifax, Nova Scotia, Canada, B3H 1V7
Location
Kingston, Ontario, Canada, K7L 2V7
Location
Mississauga, ON, Canada, L5M 2N1
Location
Montreal, QC, Canada, H1T 2M4
Location
Toronto, ON, Canada, M5G 2M9
Arms | Assigned Interventions |
---|---|
Experimental: Olaparib Treatment | Drug: Olaparib 300 mg olaparib (2×150 mg tablets) twice daily |
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