A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety
of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and
is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in
antineoplastic effects.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety, DLT, and MTD
Measured during the first cycle of treatment
Yes
United States: Food and Drug Administration
GRN163L CP05-101
NCT00310895
March 2006
March 2013
Name | Location |
---|---|
The University of Chicago Medical Center | Chicago, Illinois 60637-1470 |
Wayne State University, Karmanos Cancer Center | Detroit, Michigan 48201 |