drugset / Trial / NCT01077544

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

NCT01077544

Phase 1 Completed 15 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.

Timeline

Start
2011-04-14
Primary completion
2015-07-01
Completion
2015-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nilotinib Small molecule 230 mg/m2 Oral