CA180-226 = Dasatinib Powder for Oral Suspension Substudy [Mexico, Romania, Spain, USA]
Study title
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)
Type of study
Pediatric trials
Current status
Active, not recruiting
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.
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