Clinical trial NCT01066468: Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
Official title: A Non-randomized, Open-label Study to Characterize the Pharmacokinetics (PK) of Glivec/Gleevec® (Imatinib Mesylate) in Pediatric (Age Range 1 to Less Than 4 Years) Patients With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) or Other Glivec/ Gleevec® Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Myeloid Leukemia (CML)
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
Keywords: Chronic myeloid leukemia
CML
Philadelphia chromosome positive
acute lymphoblastic leukemia
PhGlivec,
Gleevec,
hypereosinophilic syndrome,
HES,
chronic eosinophilic leukemia,
CEL,
myelodysplastic syndrome,
MDS,
myeloproliferative disease,
MPD+ ALL
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 3
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to \<4 years of age to help develop dosing regimens


Eligibility criteria: Inclusion Criteria:

1. Patients must be 1 to less than 4 years of age at study entry
2. Written informed consent must be signed by the patient's parent or legal guardian.
3. Patients must have the diagnosis of CML or Ph+ ALL
4. Lansky score must be ≥ 50 (Table7-2)
5. Patient must have adequate end organ function as defined by

   * Total bilirubin \< 1.5 x ULN
   * SGPT (ALT) and SGOT (AST) \< 2.5 x UNL
   * Creatinine \< 1.5 x ULN

Exclusion Criteria:

1. Patients who have received drugs a) known to be metabolized by CYP3A4 or 3A5, b) are CYP inhibitors and inducers, within 2 weeks prior to Visit 2 (except for imatinib)
2. Patients who previously received radiotherapy to ≥ 25% of the bone marrow, with the exception of patients who received total body radiation as part of a preparatory regimen for hematopoetic stem cell transplant (HSCT)
3. Patients receiving antibacterial and antipyretic medication to treat active infection
4. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) \> 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
5. Patients whose parents or legal guardians, in the opinion of the Investigator, were unlikely to comply with the protocol or safety monitoring requirements

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Measure: Pharmacokinetic data o (CL/F (clearance) o V/F (Volume of distribution) o Tmax o Physiologically based pharmacokinetic (PBPK) parameters (plasma protein binding and α-1 acid glycoprotein concentration)
timeFrame: 2 PK sample collection within 21 days
Secondary outcomes:
measure: safety and tolerability of imatinib during the study period
timeFrame: study period of 21 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: