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
18 Years
N/A
Both
Ovarian, Breast, Prostate, Pancreatic, Advanced Tumours
Trial Information
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
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
at baseline, then in every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until progression
Safety Issue:
No
Principal Investigator
Jane Robertson, BSc, MBCHB, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D0810C00042
NCT ID:
NCT01078662
Start Date:
February 2010
Completion Date:
December 2013
Related Keywords:
- Ovarian
- Breast
- Prostate
- Pancreatic
- Advanced Tumours
- olaparib
- PARP inhibitors
- genetic BRCA1 mutation
- BRCA2 mutation
- solid tumour refractory
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Allentown, Pennsylvania |
