Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer (ICEBERG 1)
The purpose of the study is to see if the drug KU 0059436 (olaparib) is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced breast 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 (Olaparib) Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Breast Cancer|
- Confirmed Objective Tumour Response (According to RECIST Criteria) [ Time Frame: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. Up to 2 years. ] [ Designated as safety issue: No ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Duration of Response to Olaparib [ Time Frame: Time from response (CR or PR) to progression per RECIST criteria ] [ Designated as safety issue: No ]
- The Clinical Benefit Rate (CBR) [ Time Frame: End of study ] [ Designated as safety issue: No ]The Clinical Benefit Rate (CBR) is defined as the percentage of patients with a RECIST tumour response of confirmed CR, PR or stable disease (SD) for ≥8 weeks +/- 1 week visit window.
- Best Percent Change in Tumour Size [ Time Frame: End of study ] [ Designated as safety issue: No ]The tumour size is 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 ]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. Those patients who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where patients had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment.
- Change From Baseline in ECOG Performance Status: Improvement Rate [ Time Frame: At cycle 7 day 1 (ie, after completing 6 cycles of treatment) ] [ Designated as safety issue: No ]The change in ECOG performance status was defined as improved (meaning the ECOG score is less than the baseline value), no change (ECOG is same as at baseline), worsened (ECOG score is greater than the baseline value) or missing (the ECOG score is missing or was not recorded at baseline). If no measurement was recorded at Cycle 1 Day 1, the change was calculated in relation to the last recorded ECOG value prior to Day 1.
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: KU-0059436 (AZD2281) 100 mg BID
KU-0059436 (AZD2281) 100 mg BID
Drug: KU-0059436 (AZD2281) (PARP inhibitor)
Other Name: Olaparib
Experimental: KU-0059436 (AZD2281) 400 mg BID
KU-0059436 (AZD2281) 400 mg BID
|Drug: KU-0059436 (AZD2281) (PARP inhibitor)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494234
|United States, California|
|Los Angeles, 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|
|Dallas, Texas, United States|
|East Melbourne, Australia|
|Cambridge, United Kingdom|
|London, United Kingdom|
|Manchester, 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|