Continuation Study for Patients Who Benefited from a Previous Cancer Study with Olaparib
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04421963
This study allows patients who have completed a previous cancer study with the drug olaparib and are still benefiting from it to continue their treatment. The decision to continue is based on the doctor's assessment.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to allow patients who have been part of a previous study with the drug olaparib and are still seeing positive results to keep receiving the treatment. This decision is made by the doctor overseeing the treatment. Patients will continue with the study as long as they are benefiting from the treatment and do not meet any criteria for stopping.
Description
This study, called ROSY-O, is open to patients who have finished a previous study with olaparib and are still benefiting from the treatment. It is an international study that does not involve random selection of participants. Patients will continue their treatment from the previous study and can stay in the study indefinitely, as long as they continue to benefit and do not meet any criteria for stopping the treatment.
Eligibility Criteria
Inclusion Criteria
- You must provide signed and dated written consent to participate.
- You must currently be benefiting from treatment in a previous study with an AstraZeneca drug, as determined by your doctor.
- You must have been part of a previous cancer study with an AstraZeneca drug, specifically olaparib, and continue to benefit from the treatment. The previous study could have been open-label or blinded, with unblinding at the end of the study.
Exclusion Criteria
- You cannot have ongoing severe side effects (Grade 3 or above) that require stopping treatment at the end of the previous study.
- You cannot be taking any medications that are not allowed in this study.
- You cannot be part of any other medical research that is not compatible with this study.
- You cannot have been permanently removed from the previous study due to side effects or worsening of your condition.
- If you have local access to the drug at no cost, you may not be eligible to continue in this study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 33486 | Boca Raton | Florida |
| Research Site | 21204 | Towson | Maryland |
| Research Site | 48201 | Detroit | Michigan |
| Research Site | 55407 | Minneapolis | Minnesota |
| Research Site | 07920 | Basking Ridge | New Jersey |
| Research Site | 07601 | Hackensack | New Jersey |
| Research Site | 10032 | New York | New York |
| Research Site | 10461 | The Bronx | New York |
| Research Site | 19104 | Philadelphia | Pennsylvania |
| Research Site | 15224 | Pittsburgh | Pennsylvania |
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