Continued Olaparib for Cancer (ROSY-O Trial)

Recruiting in Palo Alto (17 mi)

+109 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients who have previously been in an oncology study with Olaparib and are still benefiting from it. They must have signed consent, not be on prohibited meds, not have unresolved high-grade toxicity or disease progression, and can't get the drug commercially for free.

Exclusion Criteria

I was removed from the main study because of side effects or my disease got worse.

I am not taking any medications that are not allowed in the study.

I have severe side effects from a previous study that stopped my treatment.

Participant Groups

The ROSY-O study aims to continue providing Olaparib to patients who were part of a previous study and are still seeing positive effects. The focus is on those with ovarian or breast cancer who've shown clinical benefits as determined by their doctor.

1Treatment groups

Experimental Treatment

Group I: OlaparibExperimental Treatment1 Intervention

Treatment