Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Study of KW-2449 in Acute Myelogenous Leukemia (AML) (Protocol Number: 2449-US-002)
To determine the maximum tolerated dose of KW-2449 in people with acute myelogenous leukemia who are not candidates for approved therapy. As well, the study will determine the response rate to KW-2449.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Study of KW-2449 in Acute Myelogenous Leukemia|
- Safety as determine by adverse event rate and dose limiting toxicity [ Time Frame: Approximately 6 months ] [ Designated as safety issue: Yes ]
- Hematologic activity/improvement, Pharmacokinetics/Pharmacodynamics [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Sequential dose escalation in separate cohorts of 3+3 design from 450 mg/day to 800 mg/day total daily dose.
KW-2449 50 mg capsules administered 3 or 4 times per day for 21-day cycles up to 6 cycles
Phase 1: To determine the maximum tolerated daily dose (MTDD) of KW 2449 when administered to subjects with AML who are not candidates for approved therapy.
This was originally a Phase 1/Phase 2 study. However, a tolerable dose that had the potential for efficacy could not be identified in Phase 1. Therefore, Phase 2 was never conducted.
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21231|
|University of Maryland, Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Carolina|
|St. Francis Hospital|
|Greenville, South Carolina, United States, 29601|