drugset / Trial / NCT00529763

Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects

NCT00529763 ↗

Phase 2 Completed 121 enrolled Bristol-Myers Squibb
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib, or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP CML and Ph+ALL).

Timeline

Start
2007-11-17
Primary completion
2009-06-17
Completion
2022-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject dasatinib anhydrous Small molecule 70 mg Oral
Subject dasatinib anhydrous Small molecule 100 mg Oral

Indications