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Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)

Sponsor
R-Pharm (Industry)
Overall Status
Completed
CT.gov ID
NCT00080262
Collaborator
(none)
125
Enrollment
45
Locations
1
Arm
34
Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Ixabepilone
Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.
Other Names:
  • BMS-247550

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response rate as determined by the IRRC []

    Secondary Outcome Measures

    1. Time to progression, duration of response, overall survival []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant

    • No more than 3 prior chemotherapy regimens in the metastatic setting

    • Must have at least one target lesion that is radiographically measurable

    • Good performance status

    • No history of or current brain or leptomeningeal disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution La Verne California United States
    2 Local Institution Meriden Connecticut United States
    3 Local Institution Jacksonville Florida United States
    4 Local Institution Baltimore Maryland United States
    5 Local Institution Boston Massachusetts United States
    6 Local Institution New York New York United States
    7 Local Institution Asheville North Carolina United States
    8 Local Institution Charlotte North Carolina United States
    9 Local Institution Pittsburgh Pennsylvania United States
    10 Local Institution Providence Rhode Island United States
    11 Local Institution Chattanooga Tennessee United States
    12 Local Institution Jackson Tennessee United States
    13 Local Institution Knoxville Tennessee United States
    14 Local Institution Nashville Tennessee United States
    15 Local Institution Houston Texas United States
    16 Local Institution San Antonio Texas United States
    17 Local Institution Salt Lake City Utah United States
    18 Local Institution Buenos Aires Argentina
    19 Local Institution Santa Fe Argentina
    20 Local Institution Montreal Quebec Canada
    21 Local Institution Besancon Cedex France
    22 Local Institution Bobigny France
    23 Local Institution Clermont-Ferrand France
    24 Local Institution Dijon Cedex France
    25 Local Institution Lyon France
    26 Local Institution Marseille Cedex 9 France
    27 Local Institution Vandoeuvre Les Nancy France
    28 Local Institution Frankfurt Hoechst Germany
    29 Local Institution Frankfurt Germany
    30 Local Institution Merida Yucatan Mexico
    31 Local Institution Chihuahua Mexico
    32 Local Institution Distrito Federal Mexico
    33 Local Institution Amsterdam Netherlands
    34 Local Institution Leiden Netherlands
    35 Local Institution Oslo Norway
    36 Local Institution Trondheim Norway
    37 Local Institution Port Elizabeth Eastern Cape South Africa
    38 Local Institution Fichardtpark Free State South Africa
    39 Local Institution Pretoria Gauteng South Africa
    40 Local Institution Overport Kwa Zulu Natal South Africa
    41 Local Institution Panorama Western Cape South Africa
    42 Local Institution Helsingborg Sweden
    43 Local Institution Lund Sweden
    44 Local Institution Malmo Sweden
    45 Local Institution Stockholm Sweden

    Sponsors and Collaborators

    • R-Pharm

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00080262
    Other Study ID Numbers:
    • CA163-081
    First Posted:
    Mar 26, 2004
    Last Update Posted:
    Jan 30, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by , ,
    Metastatic Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jan 30, 2017