A Multi-center, Open-label, Pharmacokinetic Study of Oral Nilotinib in Pediatric Patients With Gleevec® (Imatinib)-Resistant/Intolerant Ph+ CML Chronic Phase (CP) or Accelerated Phase (AP) or With Refractory/Relapsed Ph+ ALL
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
pharmacokinetics in pediatric patients measuring steady state and clearance of nilotinib on days 1, 8, 15, 22 & 28
30 days
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CAMN107A2120
NCT01077544
April 2011
January 2016
Name | Location |
---|---|
University of Miami | Miami, Florida 33136 |
Levine Children's Hospital | Charlotte, North Carolina 28204 |
University of Alabama Comprehensive Cancer Center University of Alabama | Birmingham, Alabama 35294 |
Children's Hospital of Orange County CHOC | Orange, California 92868-3874 |
Stanford University Medical Center Oncology | Palo Alto, California 94304 |
Indiana University Riley Hospital for Children | Indianapolis, Indiana 46202 |
Cincinnati Children's Hospital Medical Center Cincinnati Children's Hosp | Cincinnati, Ohio 45229-3039 |
Children's Hospital of Philadelphia Pediatric Oncology Clinic | Philadelphia, Pennsylvania 19104 |
Ann & Robert H. Lurie Children's Hospital of Chicago Ann&Robert Lurie | Chicago, Illinois 60611 |