CA180-226 = Dasatinib Powder for Oral Suspension Substudy [Mexico, Romania, Spain, USA]

Type of study

Pediatric trials

Current status

Active, not recruiting

Study title

CA180-226 = Dasatinib Powder for Oral Suspension PK Substudy

Scientific title

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib (ClinicalTrials.gov no NCT00777036)

What is the purpose of the study

This is a pharmacokinetic (PK) substudy to evaluate how dasatinib powder formulation in oral solution and dasatinib powder for oral suspension are absorbed, distributed, metabolized in the body and excreted from the body.

What will happen during the study

Key inclusion criteria

Children up to 18 years old who have chronic phase chronic myeloid leukemia (CP CML) and are taking daily dasatinib (tablets or powder for oral suspension)

Key exclusion criteria

Where can I find additional information

Study sponsor

Bristol-Myers Squibb

Scientific lead / contact

Mariana Sacchi
mariana.sacchi@bms.com

Principal investigator

Multiple

Study centers / principal investigators

Mexico
Mexico City
Instituto Nacional De Pediatria

Romania
Bucharest
Institutul Clinic Fundeni

Spain
Madrid
Hospital Universitario Nino Jesus

USA
Boston
Dana Farber Cancer Institute

Chicago
Children’s Hospital of Chicago

Houston
Texas Children’S Cancer Center