CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 724 enrolled
Drug / intervention
dasatinib +3 moredrug
Likely dose
Dasatinib 50 mg, 70 mg, 100 mg, or 140 mg orally (BID or QD depending on arm)AI-extracted
Key inclusion· 4
  • ✓Philadelphia chromosome positive (Ph+) or BCR/ABL+ chronic phase chronic myeloid leukemia with primary or acquired hematologic resistance to imatinib mesylate OR intolerance to imatinib mesylate
  • ✓Age 18 years or older
  • ✓Adequate hepatic function
  • ✓Adequate renal function
Key exclusion· 9
  • ✕Pregnant or breastfeeding women
  • ✕Eligible and willing to undergo transplantation during screening
  • ✕Serious uncontrolled medical disorder or active infection impairing ability to receive protocol therapy
  • ✕Uncontrolled or significant cardiovascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00123474
NCT00123474Phase 3Completed
CompareCT.gov

A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Bristol-Myers Squibb·interventional·Posted Jul 25, 2005·Updated Aug 25, 2016

In Brief

A Phase 3 clinical trial evaluating dasatinib for Myeloid Leukemia, Chronic, Chronic-Phase. Completed, enrolled 724 participants across 137 sites in 31 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloid Leukemia, Chronic, Chronic-Phase
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2005
Enrollment StartJul 1, 2005
Primary CompletionSep 1, 2006
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.9 years ago

Interventions

dasatinibdrug

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

dasatinibdrug

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

dasatinibdrug

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

dasatinibdrug

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