Pharmacokinetics of cytostatic agents and tyrosine kinase inhibitors in pediatric oncology

Pharmacokinetics of cytostatic agents and tyrosine kinase inhibitors in pediatric oncology - PINOCCHIO-study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55747

Enrollment

810

Registered

2018-02-09

Start date

2019-02-27

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, oncology

Interventions

None listed

Eligibility

Age

No minimum to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters (i.e. clearance and volume of distribution) will be assessed using non-linear mixed effects modelling (NONMEM). Influence of relevant co-variates will be assessed by standard model building methods.	—

Countries

Netherlands

Contacts

Public ContactC.M. Zwaan

Prinses Máxima Centrum voor Kinderoncologie

c.m.zwaan@prinsesmaximacentrum.nl088 972 72 72

Outcome results