NCT00779480

Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Study of KW-2449 in Acute Myelogenous Leukemia (AML) (Protocol Number: 2449-US-002)

Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Study of KW-2449 in Acute Myelogenous Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myelogenous Leukemia (AML)

Interventions

Type	Name	Description
DRUG	KW-2449	KW-2449 50 mg capsules administered 3 or 4 times per day for 21-day cycles up to 6 cycles

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-04-01
• Completion: 2010-12-01
• First posted: 2008-10-24
• Last updated: 2024-04-25

Locations

4 sites across 1 country: United States