Active — Not RecruitingPhase 3

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

United States185 participantsStarted 2020-08-04

Plain-language 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 treatment at the end of such studies, as judged by the Investigator.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Safety follow up

Timeframe: Baseline up to approximately 10 years

Trial details

NCT IDNCT04421963

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-06

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