Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01019577

First received: November 24, 2009

Last updated: February 3, 2010

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 24, 2009

Last Updated Date

February 3, 2010

Start Date ^ICMJE

October 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess the tumor response using RECIST Criteria to determine the best overall response and response rate [ Time Frame: For a maximum of 9 3-week cycles or until unacceptable toxicity ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01019577 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
To evaluate the duration of achieved responses [ Time Frame: For a maximum of 9 3-week cycles or until unacceptable toxicity ] [ Designated as safety issue: Yes ]
To evaluate time to progression (TTP) [ Time Frame: For a maximum of 9 3-week cycles or until unacceptable toxicity ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Official Title ^ICMJE

Phase II Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Brief Summary

The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

Drug: Ixabepilone

Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles

Other Names:

Ixempra
BMS-247550

Study Arm (s)

Experimental: Ixabepilone

Intervention: Drug: Ixabepilone

Publications *

Not Provided

* 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

Estimated Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women aged 20 years or older
Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination

Exclusion Criteria:

Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2

Gender

Female

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01019577

Other Study ID Numbers ^ICMJE

CA163-107

Has Data Monitoring Committee

Yes

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

November 2009

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

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