CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
Dasatinibdrug
Likely dose
Dasatinib 70 mg orally twice dailyAI-extracted
Key inclusion· 2
  • ✓Myeloid blast phase chronic myeloid leukemia
  • ✓Resistant or intolerant to imatinib mesylate
Key exclusion· 8
  • ✕Eligible and willing to undergo transplantation
  • ✕Serious uncontrolled medical disorder or active infection
  • ✕Uncontrolled or significant cardiac disease (CHF, recent MI, etc.)
  • ✕Medications that may affect heart rhythm

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

Search/NCT00101816
NCT00101816Phase 2Completed
CompareCT.gov

A Phase II Study of BMS-354825 in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

Bristol-Myers Squibb·interventional·Posted Jan 14, 2005·Updated Aug 10, 2010

In Brief

A Phase 2 clinical trial evaluating Dasatinib for Chronic Myeloid Leukemia and Blast Crisis. Completed, enrolled 124 participants across 62 sites in 20 countries.

Detailed Summary

The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloid Leukemia, Blast Crisis
CountriesAustralia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Philippines, Singapore, South Korea, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 14, 2005
Enrollment StartDec 1, 2004
Primary CompletionAug 1, 2006
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 21.5 years ago

Interventions

Dasatinibdrug

Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.