Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer (ICEBERG 2)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Ovarian Cancer|
- Confirmed objective tumour response (according to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: End of study ] [ Designated as safety issue: No ]Number of patients with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
- Clinical Benefit (CB) [ Time Frame: End of study ] [ Designated as safety issue: No ]Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)
- Duration of response [ Time Frame: End of study ] [ Designated as safety issue: No ]Duration of response to olaparib
- Best percentage change in tumour size [ Time Frame: End of study ] [ Designated as safety issue: No ]The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
- Progression-Free Survival (PFS) [ Time Frame: End of study ] [ Designated as safety issue: No ]Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
|United States, California|
|Duarte, California, United States|
|Los Angeles, California, United States|
|San Francisco, California, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, New York|
|New York, New York, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, Texas|
|Houston, Texas, United States|
|London, United Kingdom|
|Study Director:||James Carmichael, BSc MBChB MD FRCP||KuDOS Pharmaceuticals Limited|
|Principal Investigator:||Andrew Tutt, PhD MRCP FRCR||Guy's and St Thomas's NHS Foundation Trust, London, UK|