Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib

Running, not enrolling · Phase 3

Conditions studied: Ovarian Cancer, Breast Cancer

In brief

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.

Key facts

Study ID

NCT04421963

Run by

AstraZeneca

People needed

185

Starts

2020-08-04

Expected to finish

2027-04-06

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Towson, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Basking Ridge, New Jersey, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Willow Grove, Pennsylvania, United States
• Research Site — Providence, Rhode Island, United States
• Research Site — Germantown, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Leuven, Belgium
• Research Site — Plovdiv, Bulgaria
• Research Site — Plovdiv, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Halifax, Nova Scotia, Canada
• Research Site — Kingston, Ontario, Canada
• Research Site — Mississauga, Ontario, Canada
• Research Site — Ottawa, Ontario, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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