A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Chronic Lymphoproliferative Disease
Imetelstat Sodium (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. High telomerase levels and
short telomere lengths correlate with other markers of poor prognosis in patients with
chronic lymphoproliferative disease.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or recommended phase II dose of GRN163L in patients with relapsed or refractory chronic lymphoproliferative disease
First 3 weeks
Yes
Stephen Kelsey, MD
Study Director
Geron Corporation
United States: Food and Drug Administration
GRN163L CP04-151
NCT00124189
July 2005
March 2013
Name | Location |
---|---|
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Weill Medical College of Cornell University | New York, New York 10021 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
University of Texas Health Science Center | San Antonio, Texas 78284 |
Roswell Park Cancer Center | Buffalo, New York 14263 |
The Ohio State University James Cancer Hospital | Columbus, Ohio 43210 |
UT Southwestern | Dallas, Texas 75390 |