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

Trial ID or NCT#

NCT01077544

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Multi-center, Open-label, Pharmacokinetic Study of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Chronic Phase (CP) Ph+ CML, With CP or Accelerated Phase (AP) Ph+ CML Resistant/Intolerant to Imatinib and/or Dasatinib, or With Refractory/Relapsed Ph+ ALL

Eligibility Criteria

Ages Eligible for Study: 1 Year to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/ intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy - adequate renal, hepatic and pancreatic function
Exclusion Criteria:
  1. - patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug - patients receiving therapy with any medications with a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. - gastrointestinal impairment or disease that may interfere with drug absorption - liver, pancreatic or severe renal disease unrelated to disease under study - impaired cardiac function - patients who received dasatinib within 3 days of starting study drug - patients who received imatinib within 5 days of starting study drug - patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib - patients who received hematopoietic growth factors within 7 days of starting study drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug - patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active graft vs. host disease and < 3 months since SCT Other protocol-defined inclusion/exclusion criteria may apply

Contact us to find out if this trial is right for you.

Contact

Pediatric Hematology/Oncology
650-723-5535