Open label study to assess efficacy and safety of Olaparib in confirmed genetic BRCA1 or BRCA2 mutation pats
Study identifier:D0810C00042
ClinicalTrials.gov identifier:NCT01078662
EudraCT identifier:2010-022278-15
CTIS identifier:N/A
Recruitment Complete
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
Medical condition
ovarian
Phase
Phase 2
Healthy volunteers
No
Study drug
olaparib
Sex
All
Actual Enrollment
298
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 21 Feb 2010
Primary Completion Date: 31 Jul 2012
Estimated Study Completion Date: 31 Dec 2024
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. | Drug: olaparib Tablets Oral BID Other Name: Lynparza |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
