Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

Phase 1 Completed 63 enrolled Bristol-Myers Squibb Innovative Therapies For Children with Cancer Consortium · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (resistant to previous treatment) leukemia in children and adolescents. The side effects that this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.

Timeline

Start: 2006-03-31
Primary completion: 2011-05-31
Completion: 2019-05-22

Publications

Zwaan CM, Rizzari C, Mechinaud F, Lancaster DL, Lehrnbecher T, van der Velden VH, Beverloo BB, den Boer ML, Pieters R, Reinhardt D, Dworzak M, Rosenberg J, Manos G, Agrawal S, Strauss L, Baruchel A, Kearns PR. Dasatinib in children and adolescents with relapsed or refractory leukemia: results of the CA180-018 phase I dose-escalation study of the Innovative Therapies for Children with Cancer Consortium. J Clin Oncol. 2013 Jul 1;31(19):2460-8. doi: 10.1200/JCO.2012.46.8280. Epub 2013 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dasatinib anhydrous	Small molecule	60 mg/m2	Oral
Subject	dasatinib anhydrous	Small molecule	80 mg/m2	Oral
Subject	dasatinib anhydrous	Small molecule	100 mg/m2	Oral
Subject	dasatinib anhydrous	Small molecule	120 mg/m2	Oral

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

Summary

Timeline

Publications

Drugs

Indications