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
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors
Both
Advanced Solid Tumors
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 Clinic | Rochester, Minnesota 55905 |
