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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
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: Ixabepilone
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Ixabepilone
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 54
Study Start Date: October 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixabepilone Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles
Other Names:
  • Ixempra
  • BMS-247550

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019577

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01019577     History of Changes
Other Study ID Numbers: CA163-107
Study First Received: November 24, 2009
Last Updated: February 3, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epothilones
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013