Protocol EC-FV-01: A Phase 1 Study of EC145 Administered in Weeks 1 and 3 of a 4-Week Cycle
This is a Phase I, dose escalation study of EC145 administered by intravenous bolus (IV)
during weeks 1 and 3 of a 4-week cycle to patients with solid tumors refractory to current
therapies. EC145 is a drug that is specifically designed to enter cells via a folate
vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in
many human cancers. There are no previous human studies of EC145 treatment; however, lab
research (research in test tubes and/or animals) using EC145 has shown activity against
tumors in animals. This activity in animal models suggests that EC145 may be useful as
chemotherapy against human cancers.
The primary objective of this study is to determine the safety and maximum tolerated dose of
EC145 given by intravenous bolus. The efficacy of the treatment will also be measured.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD)
Dose escalation to the hightest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
No
Richard A Messmann, MD, MHS, BSc
Study Director
Endocyte
United States: Food and Drug Administration
EC-FV-01
NCT00308269
March 2006
July 2008
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |