Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats
Completed · Phase 2
Conditions studied: Ovarian, Breast, Prostate, Pancreatic, Advanced Tumours
In brief
To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response
Key facts
- Study ID
- NCT01078662
- Run by
- AstraZeneca
- People needed
- 298
- Starts
- 2010-02-21
- Expected to finish
- 2024-08-12
- Last updated by the study team
- 2025-08-13
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed documented deleterious or suspected deleterious BRCA mutation. (The presence of a loss-of-function germline mutation in the BRCA1 and/or BRCA2 gene must be confirmed prior to consent according to local practice).
- Confirmed malignant solid tumours for which no standard treatment exists
- At least one lesion (measurable and/or non measurable) at baseline that can be accurately assessed by CT/MRI and is suitable for repeated assessment at follow up visits
You may not qualify if…
- Any previous treatment with a PARP inhibitor, including olaparib
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
- Patients receiving any systematic chemotherapy, radiotherapy (except for palliative reasons) within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used)
Where it is running
- Research Site — West Hollywood, California, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Melbourne, Australia
- Research Site — Randwick, Australia
- Research Site — Cologne, Germany
- Research Site — Haifa, Israel
- Research Site — Haifa, Israel
- Research Site — Jerusalem, Israel
- Research Site — Jerusalem, Israel
- Research Site — Petah Tikva, Israel
- Research Site — Ramat Gan, Israel
- Research Site — Tel Aviv, Israel
- Research Site — Madrid, Spain
- Research Site — Lund, Sweden
Full record on ClinicalTrials.gov
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