NCT00337454

Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan

A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (planned)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: —

Summary

This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Conditions

• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	Tablets, Oral, 50mg BID, once daily, 24 weeks.
DRUG	Dasatinib	Tablets, Oral, 70mg BID, once daily, 24 weeks.
DRUG	Dasatinib	Tablets, Oral, 90mg BID, once daily, 24 weeks.
DRUG	Dasatinib	Tablets, Oral, 70mg BID, once daily, 24 weeks.
DRUG	Dasatinib	Tablets, Oral, 70mg BID, once daily, 12 weeks.
DRUG	Dasatinib	Tablets, Oral, 70mg BID, once daily, 12 weeks.

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2006-06-16
• Last updated: 2011-04-14

Locations

21 sites across 1 country: Japan