Overview

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

Status:
Completed

Trial end date:
2015-07-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Dasatinib
Imatinib Mesylate