A Phase II Trial to Evaluate the Activity of Imetelstat (GRN163L) in Patients With Essential Thrombocythemia or Polycythemia Vera Who Require Cytoreduction and Have Failed or Are Intolerant to Previous Therapy, or Who Refuse Standard Therapy
For patients with ET: To obtain a preliminary estimate of efficacy of imetelstat, as
measured by best hematologic response within the first year of therapy in patients with ET
who have failed or are intolerant to at least one prior therapy, or who have refused
standard therapy.
For patients with PV: To obtain a preliminary estimate of efficacy of imetelstat, as
measured by maintenance of Hct < 45% in men and < 42% in women (or pre-specified Hct count
that is tolerable) without phlebotomy or myelosuppressive therapy within the first year of
therapy in patients with PV who have failed or are intolerant to at least one prior therapy,
or who have refused standard therapy.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematologic Response
Primary objectives are as follows: ET patients - best hematologic response within the first year of therapy and PV patients - maintenance of Hct < 45% in men and < 42% in women (or pre-specified Hct count that is tolerable) without phlebotomy or myelosuppressive therapy within the first year of therapy. Secondary objectives, to determine the durability of hematologic response and to determine the rate of phlebotomy required within the first year of therapy.
From time of first dose (cycle 1 day 1) through end of study (12 mos after last participant is dosed)
No
Stephen Kelsey, MD FRCP FRCPath
Study Director
Geron Corporation
United States: Food and Drug Administration
CP14B015
NCT01243073
December 2010
January 2016
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
City of Hope | Duarte, California 91010 |
University of Chicago | Chicago, Illinois 60637 |
Saint Francis Hospital | Greenville, South Carolina 29601 |
MDACC - Orlando | Orlando, Florida 32806 |
Johns Hopkins University - Bunting Blaustein Cancer Research Building | Baltimore, Maryland 21205 |
Mount Sinai School of Medicine - Tisch Cancer Institute | New York, New York 10029 |