Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle
This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV)
during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who
have exhausted standard therapeutic options. EC0225 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
EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown
activity against tumors in animals. This activity in animal models suggests that EC0225 may
be useful as chemotherapy against human cancers. The primary objective of this study is to
determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The
efficacy of 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 highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
Yes
Richard A. Messmann, MD, MHS, MSc
Study Director
Endocyte
United States: Food and Drug Administration
EC-0225-01
NCT00441870
February 2007
November 2010
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
Greenebaum Cancer Center - University of Maryland Medicine | Baltimore, Maryland 21201 |