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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)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493)

Outcome Time Frame:

at the end of the study

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA190-001

NCT ID:

NCT00546247

Start Date:

January 2008

Completion Date:

March 2010

Related Keywords:

  • Advanced Solid Tumors

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007