Trial intelligence / Profile preview

Dasatinib vs Imatinib in Imatinib-Resistant Chronic Phase CML

NCT00112775Phase 2

Key facts

Status: Unknown
Start: Mar 2005
Countries: 1
Sponsor: UCLA Jonsson Comprehensive Cancer Center
Modality: Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands

Drugs: dasatinib
Conditions: chronic myeloid leukemia (CML)

Overview

Phase 2, randomised, open-label trial of dasatinib in chronic myeloid leukemia (CML) (2 arms), sponsored by UCLA Jonsson Comprehensive Cancer Center. Primary endpoint: Major Cytogenetic Response Rate at 12 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Dasatinib
BMS-354825 twice daily
Imatinib
Imatinib mesylate twice daily

Who it enrols

Adult patients with Ph+ chronic phase CML resistant to prior imatinib (400-600 mg/day), without specific BCR-ABL mutations (e.g., T315I).

Endpoints

Primary

Major Cytogenetic Response Rate12 weeks

Secondary

Major Cytogenetic Response Rateprior to crossover
Duration of Major Cytogenetic Responseprior to crossover
Time to Major Cytogenetic Responseprior to crossover
Complete Hematologic Response Rateprior to crossover
Duration of Complete Hematologic Responseprior to crossover
Time to Complete Hematologic Responseprior to crossover
Major Molecular Response Rateprior to crossover
Post-Crossover Efficacy Endpointspost-crossover

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