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Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Ovarian, Breast, Prostate, Pancreatic, Advanced Tumours

Interventions: olaparib

Countries: United States, Australia, Germany, Israel, Spain, Sweden

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Locations (14)

West Hollywood, California, United States
Philadelphia, Pennsylvania, United States
Melbourne, Australia
Randwick, Australia
Cologne, Germany
Haifa, Israel
Haifa, Israel
Jerusalem, Israel
Jerusalem, Israel
Petah Tikva, Israel
Ramat Gan, Israel
Tel Aviv, Israel
Madrid, Spain
Lund, Sweden