Study identifier:KU36-58
ClinicalTrials.gov identifier:NCT00494442
EudraCT identifier:N/A
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 ovarian cancer
Ovarian neoplasm
Phase 2
No
KU-0059436 (AZD2281)(PARP inhibitor)
Female
58
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2018 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 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.
Location
Location
Randwick, Australia, 2031
Location
Melbourne, Australia, 3000
Location
Melbourne, Parkville, Australia, VIC 3050
Location
Köln, Germany, 50931
Location
Hospitalet deLlobregat, Spain, 08907
Location
Lund, Sweden, S-221 85
Location
Los Angeles, CA, United States, 90048
Location
San Francisco, CA, United States, 94115
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 | Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral |
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