NCT01078662CompletedPhase 2
Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats
A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation
Source: ClinicalTrials.gov · Last updated 13 Aug 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 298 (actual)
- First submitted
- 1 Mar 2010
- Start date
- 21 Feb 2010
- Primary completion date
- 31 Jul 2012
- Lead sponsor
- AstraZeneca
- NCT number
- NCT01078662
- EudraCT number
- 2010-022278-15
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 298
- From 21 Feb 2010 to the primary completion date, 31 Jul 2012
- 12 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any previous treatment with a PARP inhibitor, including olaparib
- 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)
Other illness
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
Who the study is looking for
- 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
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | West Hollywood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.