Status:
ENROLLING_BY_INVITATION
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib
Lead Sponsor:
AstraZeneca
Conditions:
Ovarian Cancer
Breast Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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 tr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written ICF.
- Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.
- Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
Exclusion
- Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- Currently receiving treatment with any prohibited medication(s).
- Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Permanent discontinuation from the parent study due to toxicity or disease progression.
- Local access to commercially-available drug at no cost to the patient is permitted by local regulation.
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 6 2027
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT04421963
Start Date
August 4 2020
End Date
April 6 2027
Last Update
July 29 2025
Active Locations (110)
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1
Research Site
West Hollywood, California, United States, 90048
2
Research Site
Boca Raton, Florida, United States, 33486
3
Research Site
Towson, Maryland, United States, 21204
4
Research Site
Detroit, Michigan, United States, 48201