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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


Phase 1
N/A
18 Years
Open (Enrolling)
Both
Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia

Thank you

Trial Information

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


Inclusion Criteria:



- patients < 18 years

- imatinib resistant or intolerant Ph+ CML CP or AP 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pharmacokinetics in pediatric patients measuring steady state and clearance of nilotinib on days 1, 8, 15, 22 & 28

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107A2120

NCT ID:

NCT01077544

Start Date:

April 2011

Completion Date:

January 2016

Related Keywords:

  • Chronic Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Ph+ CML
  • Ph+ ALL
  • pediatric
  • nilotinib
  • imatinib
  • chronic phase
  • accelerated phase,
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

University of MiamiMiami, Florida  33136
Levine Children's HospitalCharlotte, North Carolina  28204
University of Alabama Comprehensive Cancer Center University of AlabamaBirmingham, Alabama  35294
Children's Hospital of Orange County CHOCOrange, California  92868-3874
Stanford University Medical Center OncologyPalo Alto, California  94304
Indiana University Riley Hospital for ChildrenIndianapolis, Indiana  46202
Cincinnati Children's Hospital Medical Center Cincinnati Children's HospCincinnati, Ohio  45229-3039
Children's Hospital of Philadelphia Pediatric Oncology ClinicPhiladelphia, Pennsylvania  19104
Ann & Robert H. Lurie Children's Hospital of Chicago Ann&Robert LurieChicago, Illinois  60611