A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma
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: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and MTD
First 3 weeks
Yes
Steve Kelsey, MD
Study Director
Geron Corporation
United States: Food and Drug Administration
CP14A004
NCT00594126
November 2007
July 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | Baltimore, Maryland 21231 |