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Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer (ICEBERG 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494234
First received: June 27, 2007
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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.


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 (Olaparib) 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: 79
Study Start Date: June 2007
Estimated Study Completion Date: December 2015
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494234

Locations
United States, California
Research Site
Los Angeles, 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
United States, Texas
Research Site
Dallas, Texas, United States
Australia
Research Site
East Melbourne, Australia
Research Site
Randwick, Australia
Germany
Research Site
Köln, Germany
Sweden
Research Site
Lund, Sweden
United Kingdom
Research Site
Cambridge, 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):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00494234     History of Changes
Other Study ID Numbers: KU36-44, D0810C00008
Study First Received: June 27, 2007
Last Updated: November 5, 2014
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 (olaparib)
BRCA1 protein
BRCA2 protein

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014