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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

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ClinicalTrials.gov Identifier: NCT01019577
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : January 30, 2017
Sponsor:
Information provided by:
R-Pharm

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Ixabepilone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ixabepilone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ixabepilone Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles
Other Names:
  • Ixempra
  • BMS-247550



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria [ Time Frame: Every cycle ]
  2. To evaluate the duration of achieved responses [ Time Frame: For a maximum of 9 3-week cycles or until unacceptable toxicity ]
  3. To evaluate time to progression (TTP) [ Time Frame: For a maximum of 9 3-week cycles or until unacceptable toxicity ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019577


Sponsors and Collaborators
R-Pharm
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01019577     History of Changes
Other Study ID Numbers: CA163-107
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

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