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Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia

NCT00103844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-08-10

Study results available
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Summary

The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

Conditions

  • Chronic Myeloid Leukemia
  • Philadelphia-Positive Myeloid Leukemia

Interventions

DRUG

Dasatinib

Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks

DRUG

Imatinib

Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-08-31
Completion
2008-03-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Norway
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00103844 on ClinicalTrials.gov