Real World Pharmacokinetics of Immune Checkpoint Inhibitors
NCT ID: NCT04833075
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2021-09-15
2023-05-15
Brief Summary
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Objective: To describe the real-world pharmacokinetics of ICIs in patients eligible for ICI treatment or already treated with ICIs.
Study design: A low-interventional cross-sectional pharmacokinetic study. Study population: Patients treated with ICIs. Intervention: A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived.
Main study parameters: Real- world pharmacokinetic parameters of ICIs: clearance, volume of distribution, serum exposure (serum concentration - time curve).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single arm
additional blood sampling (single arm)
blood sampling
A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived.
Interventions
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blood sampling
A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived.
Eligibility Criteria
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Inclusion Criteria
* Willingness and ability to provide written informed consent
* Age 18 years or older
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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Other Identifiers
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ELICIT
Identifier Type: -
Identifier Source: org_study_id
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