Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer (ICEBERG 1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00494234|
Recruitment Status : Active, not recruiting
First Posted : June 29, 2007
Results First Posted : January 26, 2015
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: KU-0059436 (AZD2281) (PARP inhibitor)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 15, 2007|
|Actual Primary Completion Date :||February 27, 2009|
|Estimated Study Completion Date :||December 31, 2019|
|Experimental: KU-0059436 (AZD2281) 100 mg BID||
Drug: KU-0059436 (AZD2281) (PARP inhibitor)
Other Name: Olaparib
|Experimental: KU-0059436 (AZD2281) 400 mg BID||
Drug: KU-0059436 (AZD2281) (PARP inhibitor)
- 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. ]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 ]
- The Clinical Benefit Rate (CBR) [ Time Frame: End of study ]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 ]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 ]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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494234
|United States, California|
|Los Angeles, California, United States, 90048|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4322|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Melbourne, Australia, 3000|
|Randwick, Australia, 2031|
|Köln, Germany, 50937|
|Lund, Sweden, 221 85|
|Cambridge, United Kingdom, CB2 0QQ|
|London, United Kingdom, SE1 9RT|
|Manchester, United Kingdom, M20 4BX|
|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|