Study identifier:KU36-44
ClinicalTrials.gov identifier:NCT00494234
EudraCT identifier:2006-006458-91
CTIS identifier:N/A
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.
Breast Neoplasms
Phase 2
No
Olaparib
Female
54
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jan 2024 by AstraZeneca
AstraZeneca
KuDOS Pharmaceuticals Ltd (a member of the AstraZeneca Group of companies)
The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.
This is a Phase II, open-label, non-comparative, international, multicenter study to assess the efficacy and safety of olaparib when given orally twice daily (bd) in participants with advanced BRCA1- or BRCA2- associated breast cancer. Two sequential participant cohorts will receive continuous oral olaparib in 28-day cycles. The first cohort will receive 400 mg bd and the second cohort will receive 100 mg bd.
Location
Location
Randwick, Australia, 2031
Location
Melbourne, Australia, 3000
Location
Köln, Germany, 50937
Location
Lund, Sweden, 221 85
Location
Manchester, United Kingdom, M20 4BX
Location
Cambridge, United Kingdom, CB2 0QQ
Location
London, United Kingdom, SE1 9RT
Location
West Hollywood, CA, United States, 90048
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 |
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