NCT01660906

Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

Conditions

• Chronic Phase Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	tablets, oral, 100 mg, Once daily, Up to12 months on study,

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-08-09
• Last updated: 2016-11-22
• Results posted: 2016-11-22

Locations

22 sites across 5 countries: United States, France, Germany, Italy, South Korea