Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-Positive Advanced Breast Cancer (ICEBERG 1)
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494234
First received: June 27, 2007
Last updated: May 14, 2009
Last verified: May 2009
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Purpose
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 breast cancer and for whom no curative therapeutic option exists.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: KU-0059436 (AZD2281)(PARP inhibitor) |
Phase 2 |
| Study Type: | Interventional |
| 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 Breast Cancer |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Objective tumour response rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical benefit rate [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
- Safety and tolerability profile [ Time Frame: assessed at each visit throught the study ] [ Designated as safety issue: No ]
| Enrollment: | 54 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Name: Olaparib
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Advanced breast cancer with positive BRCA1 or BRCA2 status
- Failed at least one prior chemotherapy
- In investigators opinion, no curative standard therapy exists
- Measurable disease
Exclusion Criteria:
- Brain metastases
- Less than 28 days since last treatment used to treat the disease
- Considered a poor medical risk due to a serious uncontrolled disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494234
Locations
| United States, California | |
| Research Site | |
| Duarte, California, United States | |
| Research Site | |
| Los Angeles, California, United States | |
| Research Site | |
| San Francisco, California, United States | |
| United States, Massachusetts | |
| Research Site | |
| Boston, Massachusetts, United States | |
| United States, New York | |
| Research Site | |
| New York, New York, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States | |
| Australia | |
| Research Site | |
| Melbourne, Australia | |
| Research Site | |
| Sydney, Australia | |
| Germany | |
| Research Site | |
| Cologne, Germany | |
| Research Site | |
| Heidelberg, Germany | |
| Research Site | |
| Kiel, Germany | |
| Research Site | |
| Munich, Germany | |
| Spain | |
| Research Site | |
| Barcelona, Spain | |
| Sweden | |
| Research Site | |
| Lund, Sweden | |
| United Kingdom | |
| Research Site | |
| London, United Kingdom | |
| Research Site | |
| Manchester, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
KuDOS Pharmaceuticals Limited
Investigators
| 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 |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00494234 History of Changes |
| Other Study ID Numbers: | KU36-44, D0810C00008 |
| Study First Received: | June 27, 2007 |
| Last Updated: | May 14, 2009 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Germany: Federal Institute for Drugs and Medical Devices Sweden: Medical Products Agency Spain: Spanish Agency of Medicines |
Keywords provided by AstraZeneca:
|
Advanced breast cancer Poly(ADP ribose) polymerases AZD2281 |
KU-0059436 BRCA1 protein BRCA2 protein |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013