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Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

Sponsor
R-Pharm (Industry)
Overall Status
Completed
CT.gov ID
NCT01018966
Collaborator
(none)
25
Enrollment
1
Arm
12
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Mar 1, 2005
Actual Study Completion Date :
Apr 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ixabepilone

Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)
Other Names:
  • Ixempra
  • BMS-247550

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT) [3-week treatment cycles until unacceptable toxicity]

    Secondary Outcome Measures

    1. To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria [3-week treatment cycles]

    2. To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot [Cycle 1 (first 3 weeks of study therapy)]

    3. To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) [3-week treatment cycles until unacceptable toxicity]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 20 years or older

    • Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors

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

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT01018966
    Other Study ID Numbers:
    • CA163-029
    First Posted:
    Nov 25, 2009
    Last Update Posted:
    Jan 30, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jan 30, 2017