Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorLeiden University Medical Center

About this trial

The aim of the study is to perform a clinical validation of the analytical method for dried blood spot microsampling of cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab or enfortumab vedotin. The secondary objective is to test the feasibility of home monitoring (microsampling TDM) of cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab or enfortumab vedotin in oncology patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide informed consent;

18 years of age or older;

Using one or more of the following drugs: Cabozantinib, Pazopanib, Sunitinib, Lenvatinib, Imatinib, Abiraterone, Enzalutamide, Nivolumab, Ipilimumab, Pembrolizumab, Atezolizumab, Bevacizumab or Enfortumab vedotin

Disqualifiers

Not able to sample themselves using a finger prick

Trial design

Design model

Single group

Treatments tested in this trial

  • Therapeutic drug monitoring with a dried blood spot and microatainer.

    Diagnostic test

    Patients who use an oral oncolytic will be asked to provide four paired whole blood (WB) samples obtained by venapuncture.

Treatment groups

360 Participants
are divided into 1 treatment group
Group A: Microsampling armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Method agreement between whole blood sample (WBS) and bry blood spot (DBS).

Blood concentrations of the oral oncolytic will be obtained 0 to 3 hours after ingestion of the oral oncolytic. Blood concentrations of immune checkpoint inhibitors will be obtained 0 hours after infusion and 15 minutes after end of the infusion. Passing-Bablok analysis will be performed to investigate a linear relationship between WBS and DBS. Bland-Altman analysis will be performed to evaluate method agreement. Method agreement between WBS and DBS was defined as ≥67% of the samples between the range of 0.80 and 1.20 (with or without correction factor following Passing-Bablok analysis)

Time frame
All samples will be collected within 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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