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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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 through 4 of a 21-day cycle, until the disease progresses
Mayo Clinic
Rochester, Minnesota, United States
Local Institution
Ottawa, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Newcastle upon Tyne, Tyne and Wear, United Kingdom
To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493)
Time frame: at the end of the study
To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493)
Time frame: every 21 days
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