Spots Global Cancer Trial Database for Real World Pharmacokinetics of Immune Checkpoint Inhibitors
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Trial Identification
Brief Title: Real World Pharmacokinetics of Immune Checkpoint Inhibitors
Official Title: Real World Pharmacokinetics of Immune Checkpoint Inhibitors
Study ID: NCT04833075
Conditions
Interventions
Study Description
Brief Summary: Rationale: 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. 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Radboudumc, Nijmegen, Gelderland, Netherlands
Contact Details
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