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Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

NCT00123474 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 724

Last updated 2016-08-25

Study results available
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Summary

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

Conditions

  • Myeloid Leukemia, Chronic, Chronic-Phase

Interventions

DRUG

dasatinib

Tablets, Oral, 50 mg BID, indefinitely, survival study

DRUG

dasatinib

Tablets, Oral, 70 mg BID, indefinitely, survival study

DRUG

dasatinib

Tablets, Oral, 100 mg QD, indefinitely, survival study

DRUG

dasatinib

Tablets, Oral, 140 mg QD, indefinitely, survival study

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-09-30
Completion
2014-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Philippines
  • Poland
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT00123474 on ClinicalTrials.gov