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A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 1)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT00546247
Collaborator
(none)
26
Enrollment
4
Locations
1
Arm
26
Duration (Months)
6.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subjects With Advanced Cancer (Schedule 1)
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Epofolate
Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1, 4, 8 and 11 of a 21-day cycle, until the disease progresses
Other Names:
  • BMS-753493

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493) [at the end of the study]

    Secondary Outcome Measures

    1. To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493) [every 21 days]

    Eligibility Criteria

    Criteria

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

    • Advanced cancer, excluding cancer in the blood

    • Availability of 10 tumor tissue slides

    Exclusion:

    • Known brain metastases

    • Severe nerve damage

    • Significant cardiovascular disease

    • Inadequate blood counts

    • Inadequate liver or kidney function

    • Inadequate thyroid function or uncontrolled thyroid disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lombardi Comprehensive Cancer Center Washington District of Columbia United States 22057
    2 Memorial Sloan Kettering Cancer Center New York New York United States 10021
    3 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    4 Local Institution Rotterdam Netherlands 3075 EA

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00546247
    Other Study ID Numbers:
    • CA190-001
    First Posted:
    Oct 18, 2007
    Last Update Posted:
    Oct 12, 2015
    Last Verified:
    Sep 1, 2015

    Study Results

    No Results Posted as of Oct 12, 2015