To assess the pharmacokinetics of various cytotoxic agents (carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, dinutuximab bèta, doxorubicin, etoposide, methotrexate, vincristine or thiotepa) and kinase inhibitors (ALK, RAS pathway, BCR…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
- No intervention
N.a.
Outcome measures
Primary outcome
<p>Pharmacokinetic parameters (i.e. clearance and volume of distribution) will be<br />
assessed using non-linear mixed effects modelling (NONMEM). Influence of<br />
relevant co-variates will be assessed by standard model building methods.</p>
Secondary outcome
<p>Not applicable</p>
Background summary
Little is known about the PK of the various classes of chemotherapy and
kinase inhibitors in children. Insight in the PK of the various
classes of chemotherapy and kinase inhibitors in children and,
especially, in infants may result in improved dosing guidelines and/or
individualized dosing regimens based on therapeutic drug monitoring, ultimately
resulting in better clinical outcome. The aim is that future dosing of children
with cancer will be evidence-based, because of the population PK data that will
be generated with this project. As the projects covers several different
chemotherapeutic drugs, the results will be highly relevant, as it will
optimize the regimen in total, instead of only studying one single drug.
Study objective
To assess the pharmacokinetics of various cytotoxic agents (carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, dinutuximab bèta, doxorubicin, etoposide, methotrexate, vincristine or thiotepa) and kinase inhibitors (ALK, RAS pathway, BCR-ABL, FLT3, VEGF-R, mTOR, NTRK, BCL2 or multikinase inhibitors) in children to
characterize the age-related changes in pharmacokinetics.
Study design
Prospective observational study
Intervention
NA
Study burden and risks
The patient has no direct benefit from participating in this study. The data
obtained in this study will be used to assess the population PK of various
classes of chemotherapeutic agents and tyrosine kinase inhibitors in children
and infants with cancer. The only consequence of study participation is that
additional blood samples (maximum of 8 samples of 1 ml) will be withdrawn at
each study moment. The here applied sampling strategy is minimally invasive,
since most of the patients that are included already have a central line or
have routine sampling planned on that day. If this is not the case, patients
will be pricked a maximum of one time extra. It is highly unlikely that the
intended number of blood collections will influence the patient*s health
status. Sampling, using a flexible time scheme, will only be requested during
regular hospital visits.
C.M. Zwaan
Heidelberglaan 25
Utrecht 3584 CS
Netherlands
088 972 72 72
c.m.zwaan@prinsesmaximacentrum.nl
C.M. Zwaan
Heidelberglaan 25
Utrecht 3584 CS
Netherlands
088 972 72 72
c.m.zwaan@prinsesmaximacentrum.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Stratum 1
1. Planned to receive carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, dinutuximab bèta, doxorubicin, etoposide, methotrexate, vincristine or thiotepa intravenously as regular treatment (standard of care);
2. Age <=18 years;
3. Informed consent form (ICF) signed prior to participation in the trial;
4. A present central line to sample blood for pharmacokinetics
Stratum 2:
1. Planned to receive ALK, RAS pathway, BCR-ABL, FLT3, VEGF-R, mTOR, NTRK, BCL2 or multikinase inhibitors;
2. Age <= 18;
3. Informed consent form (ICF) signed prior to participation in the study.
Exclusion criteria
- Already included in a clinical trial assessing PK parameters.
- Down syndrome;
- For fertile adolescent girls: pregnancy;
- Any other disease/circumstances that may influence the participation of the
subject in a negative way
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63037.078.18 |
| Research portal | NL-008480 |