Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Nilotinib

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - 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:

   - 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

Ages Eligible for Study

1 Year - 18 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pediatric Hematology/Oncology
650-723-5535
Not Recruiting