- ICH GCP
- US Clinical Trials Registry
- 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.
March 12, 2012 updated by: Novartis Pharmaceuticals
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)
This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4 years of age to help develop dosing regimens
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Moscow, Russian Federation, 117997
- Novartis Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Gleevec/Glivec
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
Time Frame: 2 PK sample collection within 21 days
|
2 PK sample collection within 21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety and tolerability of imatinib during the study period
Time Frame: study period of 21 days
|
study period of 21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
February 9, 2010
First Submitted That Met QC Criteria
February 9, 2010
First Posted (ESTIMATE)
February 10, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
March 13, 2012
Last Update Submitted That Met QC Criteria
March 12, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Myeloproliferative Disorders
- Chromosome Aberrations
- Translocation, Genetic
- Leukemia
- Leukemia, Myeloid
- Hematologic Diseases
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- CSTI571A2110
- 2010-018418-53 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Myeloid Leukemia (CML)
-
UNC Lineberger Comprehensive Cancer CenterCompletedChronic Myeloid Leukemia | Chronic Myeloid Leukemia, Chronic Phase | CML, Chronic Phase | CML - Philadelphia Chromosome | CML (Chronic Myelogenous LeukemiaUnited States
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.RecruitingCML, Chronic Phase | CML, Accelerated PhaseChina
-
Il-Yang Pharm. Co., Ltd.RecruitingChronic Myeloid Leukemia, Chronic Phase | CML, Chronic Phase | CML, Refractory | CML - Philadelphia ChromosomeTurkey, Korea, Republic of, Russian Federation, Ukraine
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedAccelerated Phase Chronic Myelogenous Leukemia (CML) | Blast Phase Chronic Myelogenous Leukemia (CML) | Chronic Phase Phase Chronic Myelogenous Leukemia (CML) | Philadelphia Chromosome Positive (Ph+) Phase Chronic Myelogenous Leukemia (CML)United States
-
Associazione Italiana Pazienti Leucemia Mieloide...Not yet recruitingChronic Myeloid Leukemia (CML)Italy
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.Not yet recruiting
-
University of JenaNovartis Pharmaceuticals; Ludwig-Maximilians - University of MunichActive, not recruiting
-
Hybrigenics CorporationUnknown
-
University Hospital, Clermont-FerrandInstitut Paoli-Calmettes; CH Annecy Genevois; CHRU Lille, hematology department; Institut Bergonié Bordeaux, hematology department and other collaboratorsUnknownChronic Myeloid Leukemia (CML) | Chronic PhaseFrance
-
University Hospital, AngersActive, not recruitingChronic Myeloid Leukemia (CML)France
Clinical Trials on Gleevec/Glivec
-
University of AarhusCompletedNephrogenic Systemic FibrosisDenmark
-
Novartis PharmaceuticalsCompletedGastrointestinal Stromal TumorsJapan
-
Novartis PharmaceuticalsCompletedPhiladelphia Chromosome Positive Acute Lymphocytic Leukemia
-
Novartis PharmaceuticalsCompletedSystemic Sclerosis, SclerodermaUnited States, Germany, Italy, Switzerland, United Kingdom
-
University of Milano BicoccaCompletedChronic Myeloid LeukemiaCanada, Germany, Israel, Italy, Spain
-
Novartis PharmaceuticalsCompletedCHRONIC MYELOGENOUS LEUKEMIACanada, Australia, Spain, Argentina, France, Brazil
-
Gustave Roussy, Cancer Campus, Grand ParisTerminated
-
King Faisal Specialist Hospital & Research CenterCompleted
-
Novartis PharmaceuticalsCompletedUnresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)United States, Finland, Australia
-
Novartis PharmaceuticalsCompletedChronic Myelogenous LeukemiaChina, Argentina, Russian Federation, Germany, Guatemala, Panama, Colombia, Mexico, Brazil, India, Poland, Venezuela