Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-Positive Advanced Breast Cancer - Full Text View

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.

First Received on June 27, 2007. Last Updated on May 14, 2009 History of Changes

Sponsor:	AstraZeneca
Collaborator:	KuDOS Pharmaceuticals Limited
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00494234

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 II

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: AZD 2281

U.S. FDA Resources

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:

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

Additional Information:

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, Arun B, Loman N, Schmutzler RK, Wardley A, Mitchell G, Earl H, Wickens M, Carmichael J. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet. 2010 Jul 24;376(9737):235-44. Epub 2010 Jul 6.

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 February 09, 2012