Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01066468

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)	Drug: Gleevec/Glivec	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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 Start Date :

Oct 1, 2010

Actual Primary Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gleevec/Glivec	Drug: Gleevec/Glivec Other Names: STI571

Arm

Intervention/Treatment

Experimental: Gleevec/Glivec

Drug: Gleevec/Glivec

Other Names:

STI571

Outcome Measures

Primary Outcome Measures

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) [2 PK sample collection within 21 days]

Secondary Outcome Measures

safety and tolerability of imatinib during the study period [study period of 21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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)
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)
Patients receiving antibacterial and antipyretic medication to treat active infection
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
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