CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 121 enrolled
Drug / intervention
Dasatinibdrug
Likely dose
Dasatinib 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00529763
NCT00529763Phase 2Completed
CompareCT.gov

A Phase II Study to Determine the Activity of Dasatinib Administered Orally (PO) at a Dose of 100 mg Once Daily (QD) in Chronic Phase Chronic Myelogenous Leukemia (CML), at a Dose of 70 mg Twice Daily (BID) in Advanced Phase Chronic Myelogenous Leukemia (CML) Chinese Subjects Who Are Resistant to or Intolerant of Imatinib Mesylate (Gleevec®)

Bristol-Myers Squibb·interventional·Posted Sep 14, 2007·Updated May 8, 2023

In Brief

A Phase 2 clinical trial evaluating Dasatinib for Leukemia. Completed, enrolled 121 participants across 14 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartNov 17, 2007
Primary CompletionJun 17, 2009
Study CompletionApr 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.8 years ago

Interventions

Dasatinibdrug

Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study