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A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline

Sponsor
R-Pharm (Industry)
Overall Status
Completed
CT.gov ID
NCT01027208
Collaborator
(none)
20
Enrollment
14
Locations
1
Arm
1
Duration (Months)
1.4
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline And Who Are Taxane Resistant Who Have Completed Study CA163107 And Who Are Benefiting From Continuation On Therapy With Ixabepilone
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Jan 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ixabepilone

Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m²
Other Names:
  • Ixempra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator [21-day cycles until documented disease progression or unacceptable toxicity]

    2. To evaluate the frequency and the severity of observed adverse reactions in treated patients, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [21-day cycles until documented disease progression or unacceptable toxicity]

    Secondary Outcome Measures

    1. Secondary objectives will be assessed by combining data with the previous Phase II study CA163107 [21-day cycles until documented disease progression or unacceptable toxicity]

    2. To evaluate the antitumor response according to the RECIST criteria [21-day cycles until documented disease progression or unacceptable toxicity]

    3. To evaluate the duration of achieved responses [21-day cycles until documented disease progression or unacceptable toxicity]

    4. To evaluate time to progression (TTP) [21-day cycles until documented disease progression or unacceptable toxicity]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Local Institution Nagoya Aichi Japan 464-8681
    2 Local Institution Kashiwa-Shi Chiba Japan 277-0882
    3 Local Institution Fukuoka-Shi Fukuoka Japan
    4 Local Institution Matabashi-Shi Gunma Japan 371-8511
    5 Local Institution Kagoshima-Shi Kagoshima Japan 892-0833
    6 Local Institution Isehara-Shi Kanagawa Japan 259-1193
    7 Local Institution Niigata-Shi Niigata Japan 951-8566
    8 Local Institution Iruma-Gun Saitama Japan 350-0495
    9 Local Institution Utsunomiya Tochigi Japan 320-0834
    10 Local Institution Bunkyo-Ku Tokyo Japan 113-8677
    11 Local Institution Chuo-Ku Tokyo Japan 104-0045
    12 Local Institution Toshima-Ku Tokyo Japan 170-8455
    13 Local Institution Saitama Japan
    14 Local Institution Tokyo Japan

    Sponsors and Collaborators

    • R-Pharm

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01027208
    Other Study ID Numbers:
    • CA163-130
    First Posted:
    Dec 7, 2009
    Last Update Posted:
    Jan 30, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jan 30, 2017