To determine the real-world pharmacokinetics of ICIs.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At multiple time points, blood samples will be obtained to determine the
following pharmacokinetic characteristics of ICIs:
- Trough concentration (Cmin)
- Peak concentration (Cmax)
- Clearance (Cl) at baseline (Clbl) and change in clearance (compared to Cl at
end of treatment) (ΔCl), e.g. by Bayesian estimation using established and
validated population pharmacokinetic models, as published by the manufacturer
- Volume of distribution (Vd)
Secondary outcome
n/a
Background summary
Real-world pharmacokinetic data from cancer patients treated with immune
checkpoint inhibitors (ICIs) are sparse. Moreover, pharmacokinetic parameters
may be associated with response to ICI treatment and may act as a predictive or
early response biomarker.
Study objective
To determine the real-world pharmacokinetics of ICIs.
Study design
The current study will be a low-interventional cross-sectional pharmacokinetic
study in NSCLC patients who are, or will be treated, with ICIs in line with
routine care.
Study burden and risks
The nature and extent of burden and risks associated with participation are
considered negligible, since only a maximum of 75 mL of blood will be drawn
from subjects. Approximately one-third will be drawn during routine blood
sampling using an already present cannula. This study can, therefore, be
considered a low interventional clinical trial. There will be no individual
benefit from participation in this study. However, participation in this study
will contribute to increased understanding of real-world pharmacokinetics of
ICIs.
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- Treatment with the ICIs mentioned in paragraph 4.1
- Willingness and ability to provide written IC
- Age 18 years or older
Exclusion criteria
Since we aim to assess the real-world pharmacokinetics, we will not make use of
any exclusion criteria.
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 | EUCTR2021-001509-66-NL |
| ClinicalTrials.gov | NCT04833075 |
| CCMO | NL77286.091.21 |