Tolerability and PK/PD of Multiple Oral Doses of CT53518 in Patients With Acute Myelogenous Leukemia
This is a Phase 1, open label, dose escalating study at five clinical sites to determine
dose limiting toxicity (DLT), maximum tolerated dose (MTD), pharmacokinetics, and the effect
on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 in
patients with Acute Myelogenous Leukemia (AML) and myelodysplastic syndrome. This study
will confirm the tolerability and assess the effects on the peripheral and bone marrow blast
count of an oral 28-day course of CT53518 at or near the maximum tolerated dose in patients
with AML displaying a specified mutation of the FLT-3 gene, internal tandem duplication
(ITD).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
01-301
NCT00064584
May 2002
July 2005
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Oregon Health Sciences University | Portland, Oregon |
Ohio State University Medical Center | Columbus, Ohio 43210 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |