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:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2007

Last Updated Date

May 14, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective tumour response rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Objective tumour response rate [ Time Frame: 4 months ]

Change History

Complete list of historical versions of study NCT00494234 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Clinical benefit rate [ Time Frame: every 2 months ]
Safety and tolerability profile [ Time Frame: assessed at each visit throught the study ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

Drug: KU-0059436 (AZD2281)(PARP inhibitor)

oral

Other Name: Olaparib

Study Arm (s)

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Germany, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00494234

Other Study ID Numbers ^ICMJE

KU36-44, D0810C00008

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

KuDOS Pharmaceuticals Limited

Investigators ^ICMJE

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

Information Provided By

AstraZeneca

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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