Primary: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetic data:
* CL/F
* V/F
* Tmax
* PBPK parameters
* Cmax
* AUC
Secondary outcome
Safety and tolerability of imatinib during the study period (including
recording of adverse events and serious adverse events, monitoring hematology
and blood chemistry, measurement of vital signs and performance of physical
examinations, documentation of concomitant medication and therapies).
Background summary
Currently, there is very limited experience with the treatment of children
below 2 years of age and only limited experience treating children younger than
4 years of age with imatinib. The data from this study will help to expand the
imatinib PBPK and pop PK model in children in the age range from 1 to less than
4, as well as to help develop appropriate and accurate imatinib dosing
regimens.
Study objective
Primary: To characterize the pharmacokinetics of imatinib in pediatric patients
age 1 to less than 4 years via appropriate integrated PBPK and pop PK
approaches
Study design
Non-randomized, open-label study.
Intervention
Imatinib mesylate (Gleevec/Glivec) at daily dose 260 mg/m2 to 340 mg/m2.
Study burden and risks
Imatinib can have the following side-effects:
Swelling (fluid retention), nausea, muscle cramps, musculoskeletal pain,
diarrhea, rash, fatigue, headache, join pain, abdominal pain, inflammation of
the nasal cavity and pharynx, hemorrhage, muscle pain, vomiting, indigestion,
cough, pain of the pharynx and larynx, upper respiratory tract infection,
dizziness, fever, increased weight, insomnia, depression, influenza and
constipation.
There is a risk of skin irritation, bleeding, bruising, pain or infection at
the site where blood will be drawn.
Lichstrasse 35
4056 Basel
CH
Lichstrasse 35
4056 Basel
CH
Listed location countries
Age
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 or other imatinib indicated hematological disorders.
4. Lansky score must be >= 50
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 guardian, in the opinion of the investigator, are unlikely to comply with the protocol or safety monitoring requirements
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-018418-53-NL |
| ClinicalTrials.gov | NCT01066468 |
| CCMO | NL33071.078.10 |