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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

NCT04421963

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Ovarian Cancer, Breast Cancer

Interventions: Olaparib

Countries: United States, Belgium, Bulgaria, Canada, China, Czechia, Denmark, Finland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (107)
  • Boca Raton, Florida, United States
  • Towson, Maryland, United States
  • Detroit, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Basking Ridge, New Jersey, United States
  • Hackensack, New Jersey, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Willow Grove, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Germantown, Tennessee, United States
  • Houston, Texas, United States
  • Leuven, Belgium
  • Plovdiv, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Halifax, Nova Scotia, Canada
  • Kingston, Ontario, Canada
  • Mississauga, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Québec, Quebec, Canada
  • Changchun, China
  • + 77 more on CT.gov