A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 1)
- Registration Number
- NCT00546247
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Epofolate -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (4)
Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution
🇳🇱Rotterdam, Netherlands
Lombardi Comprehensive Cancer Center🇺🇸Washington, District of Columbia, United States