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OpenTrials
Active, Not Recruiting

NCT Number: NCT04421963

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olaparib

Drug

300 mg olaparib (2×150 mg tablets) twice daily

Primary outcomes

  1. Safety follow up

    Time frame: Baseline up to approximately 10 years

    Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ROSY-O

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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