Clinical trial · Interventional
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib
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
NCT04421963CI-TRIAL-00114582ROSY-Oactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olaparib | Drug | Olaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Olaparib
- description
- Treatment
- interventionNames
- Drug: Olaparib
Primary outcomes (1)
- measure
- Safety follow up
- timeFrame
- Baseline up to approximately 10 years
- description
- Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.