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Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib

NCT00101660 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2012-03-02

Study results available
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Summary

The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.

Conditions

  • Chronic Myeloid Leukemia
  • Philadelphia-Positive Myeloid Leukemia

Interventions

DRUG

Dasatinib

Tablets; oral; 70 mg BID, depending on response

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-09-30
Completion
2008-04-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Peru
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT00101660 on ClinicalTrials.gov