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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04421963

ROSY-O is an open-label, non-randomised, international trial for patients who completed a parent study with olaparib and continue to benefit from it. Eligible patients must have signed consent and be deriving clinical benefit from an AstraZeneca study. Participants will receive 300 mg olaparib (2×150 mg tablets) twice daily until discontinuation criteria are met.

Patient Parameters

Program Overview

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.

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 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

Eligibility Criteria

Inclusion Criteria

  1. Provision of signed and dated, written ICF.
  2. 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.
  3. 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

  1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
  2. Currently receiving treatment with any prohibited medication(s).
  3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  4. Permanent discontinuation from the parent study due to toxicity or disease progression.
  5. Local access to commercially-available drug at no cost to the patient is permitted by local regulation.

Locations

FACILITYZIPCITYSTATE
Research Site33486Boca RatonFlorida
Research Site21204TowsonMaryland
Research Site48201DetroitMichigan
Research Site55407MinneapolisMinnesota
Research Site07920Basking RidgeNew Jersey
Research Site07601HackensackNew Jersey
Research Site10032New YorkNew York
Research Site10461The BronxNew York
Research Site19104PhiladelphiaPennsylvania
Research Site15224PittsburghPennsylvania

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