CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 197 enrolled
Drug / intervention
Dasatinibdrug
Likely dose
Dasatinib 70 mg orally twice dailyAI-extracted
Key inclusion· 5
  • ✓Philadelphia chromosome positive (PH+) or BCR/ABL positive accelerated phase CML with primary or acquired resistance to imatinib or imatinib intolerance
  • ✓Prior imatinib exposure (not necessarily most recent CML therapy)
  • ✓Age 18 years or older
  • ✓Adequate hepatic function
Key exclusion· 11
  • ✕Pregnant or breastfeeding women
  • ✕Eligible for and willing to undergo transplantation during screening
  • ✕Serious uncontrolled medical disorder or active infection impairing ability to receive therapy
  • ✕Uncontrolled or significant cardiovascular disease

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

Search/NCT00101647
NCT00101647Phase 2Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Jan 13, 2005·Updated Apr 15, 2011

In Brief

A Phase 2 clinical trial evaluating Dasatinib for Chronic Myelogenous Leukemia. Completed, enrolled 197 participants across 70 sites in 23 countries.

Detailed Summary

The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia
CountriesArgentina, Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Peru, Philippines, Singapore, South Korea, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 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