NCT01030718

Rollover Study of BMS-354825 in Patients With CML and Ph+ALL

A Study to Document the Long-Term Safety and Efficacy of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Previous Treatment and Have Completed the Previous Phase I/II Protocol (CA180-031/NCT00337454)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)

Conditions

• Chronic Myelogenous Leukemia
• Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	dasatinib	Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-12-11
• Last updated: 2010-12-14
• Results posted: 2010-12-14