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:2006-006458-91
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 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
Olaparib
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: 21 Dec 2022
Study design
Allocation: Non-randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2024 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: Olaparib 100 mg Participants will receive two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met. | Drug: Olaparib Participants will receive capsules of olaparib orally as stated in arm description. Other Name: AZD2281 Other Name: KU-0059436 |
| Experimental: Olaparib 400 mg Participants will receive eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met. | Drug: Olaparib Participants will receive capsules of olaparib orally as stated in arm description. Other Name: AZD2281 Other Name: KU-0059436 |
Contacts
Investigators
Principal Investigator
James Carmichael
KuDOS Pharmaceuticals Ltd (a member of the AstraZeneca group of companies)
