Phase I Nilotinib in Children with Philadelphia Chromosome-positive (Ph+) CML or ALL

Not Recruiting

Trial ID: NCT01077544

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

Stanford Investigator(s)

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

Intervention(s):

drug: Nilotinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pediatric Hematology/Oncology
650-723-5535

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