Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01078662
First received: March 1, 2010
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Breast Prostate Pancreatic Advanced Tumours |
Drug: olaparib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 [ Time Frame: at baseline, then in every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- assessment of objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR) and disease control rate (DCR) [ Time Frame: at baseline, then in every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until progression ] [ Designated as safety issue: No ]
- safety and tolerability by collection of adverse events, haematology, clinical chemistry data, vital signs [ Time Frame: at screening, 3x within 1st month and then every 4 weeks ] [ Designated as safety issue: Yes ]
- Exploratory outcome measure; to enable a potential retrospective comparison of previously determined genetic BRCA mutation status taken from blood sample collection [ Time Frame: At screening visit ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
olaparib 400mg BD
|
Drug: olaparib
400mg (8 x 50mg capsules), oral BID until progression of the disease
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078662
Locations
| United States, California | |
| Research Site | |
| Los Angeles, California, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States | |
| Australia, New South Wales | |
| Research Site | |
| Randwick, New South Wales, Australia | |
| Australia, Victoria | |
| Research Site | |
| East Melbourne, Victoria, Australia | |
| Germany | |
| Research Site | |
| Koln, Germany | |
| Israel | |
| Research Site | |
| Haifa, Israel | |
| Research Site | |
| Jerusalem, Israel | |
| Research Site | |
| Petach Tikva, Israel | |
| Research Site | |
| Tel-hashomer, Israel | |
| Spain | |
| Research Site | |
| Barcelona, Cataluna, Spain | |
| Sweden | |
| Research Site | |
| Lund, Sweden | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jane Robertson, BSc, MBCHB, MD | AstraZeneca |
| Principal Investigator: | Bella Kaufman, MD | Chaim Sheba Medical Centre, Tel Hashomer, Israel |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01078662 History of Changes |
| Other Study ID Numbers: | D0810C00042 |
| Study First Received: | March 1, 2010 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Israel: Ethics Commission Israel: Ministry of Health United States: Institutional Review Board Germany: Ethics Commission Germany: Ministry of Health Spain: Ethics Committee Spain: Ministry of Health Sweden: Regional Ethical Review Board Sweden: The National Board of Health and Welfare |
Keywords provided by AstraZeneca:
|
olaparib PARP inhibitors genetic BRCA1 mutation BRCA2 mutation solid tumour refractory |
ClinicalTrials.gov processed this record on May 16, 2013