Study to assess the efficacy and safety of a PARP inhibitor for the treatment of BRCA-positive advanced breast cancer - ICEBERG 1
Study identifier:KU36-44
ClinicalTrials.gov identifier:NCT00494234
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase II open-label, non-comparative, international, multicentre study to assess the efficacy and safety of KU 0059436 (olaparib) given orally twice daily in patients with advanced BRCA1 or BRCA2 associated breast cancer
Medical condition
Breast Neoplasms
Phase
Phase 2
Healthy volunteers
No
Study drug
KU-0059436 (AZD2281) (PARP inhibitor)
Sex
Female
Actual Enrollment
54
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 15 Jun 2007
Primary Completion Date: 27 Feb 2009
Study Completion Date: 07 Dec 2022
Study design
Allocation: Non-randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2022 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
KuDOS Pharmaceuticals Ltd (a member of the AstraZeneca Group of companies)
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: KU-0059436 (AZD2281) 100 mg BID | Drug: KU-0059436 (AZD2281) (PARP inhibitor) oral Other Name: Olaparib |
| Experimental: KU-0059436 (AZD2281) 400 mg BID | - |
Contacts
Investigators
Principal Investigator
James Carmichael
KuDOS Pharmaceuticals Ltd (a member of the AstraZeneca group of companies)
