A Multicenter, Open-Label, 2-Stage, Phase II Study of Single-Agent Obatoclax Mesylate Administered For Three Consecutive Days Every 2 Weeks to Older Patients With Previously Untreated Acute Myeloid Leukemia (AML)
The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by
a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will
randomize 16 patients in to one of two cohorts: 1) patients receiving obatoclax administered
by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by
a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and
safety in the Pilot Schedule portion of the study will then be utilized in the Phase II
portion of the study.
Interventional
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.
4 weeks
No
Jean Viallet, MD
Study Director
Gemin X Pharmaceuticals
United States: Food and Drug Administration
GEM016
NCT00684918
April 2008
December 2009
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
St. Joseph Mercy Hospital | Pontiac, Michigan 48341-2985 |
St. Vincent's Comprehensive Cancer Center | New York, New York 10011 |
Northwestern University | Chicago, Illinois 60611 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Michigan State University - Breslin Cancer Center | East Lansing, Michigan 48824-1313 |
The University of Iowa | Iowa City, Iowa 52242 |
University of Michigan Health System | Ann Arbor, Michigan |
Benaroya Research Institute at Virginia Mason | Seattle, Washington 98101 |
University of Kansas Medical Center Research Institute | Westwood, Kansas 66205 |
Legacy Emanuel Hospital & Health Center | Portland, Oregon 97210 |
Penn State Hershey Cancer Institute-Clinical Trials Office | Hershey, Pennsylvania 17033 |