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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 2)


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 2)


Inclusion Criteria:



- Advanced cancer, excluding cancer in the blood

- Availability of 10 tumor tissue slides

Exclusion Criteria:

- 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:

CA190-002

NCT ID:

NCT00550017

Start Date:

December 2007

Completion Date:

March 2010

Related Keywords:

  • Advanced Solid Tumors

Name

Location

Mayo ClinicRochester, Minnesota  55905