A Phase I Open-Label Study to Evaluate the Safety and Tolerability of Escalating Doses of GM-CT-01 in the Presence and Absence of 5-Fluorouracil (5-FU) in Subjects With Advanced Solid Tumors
5-Fluorouracil is a chemotherapy drug commonly used in cancer patients. Patients with
different type of solid tumors who have failed standard, approved treatments can be enrolled
in the study. Escalated doses of GM-CT-01 will be given alone in Cycle 1, and in
combination with 5-fluorouracil in cycle 2. Patients will be on study for approximately 60
days for determination of safety. However, with patient consent treatment can continue until
disease progression is determined by CT scan. The study secondary reason is to determine
whether treatment has stabilize the tumors or change it in size (get bigger, smaller or stay
the same)after Cycle 2 and any additional cycles of treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
60 days - two cycles of treatment
Marilyn C Pike, M.D., Ph.D.
Consultant to Pro-Pharmaceuticals, Inc.
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756|
|Ochsner Cancer Institute||New Orleans, Louisiana 70121|
|Florida Oncology Associates||Orange Park, Florida 32073|