C64
Conditions
Interventions
Group 1: Patients participating in the study will have a venous and (an optional additional) capillary blood sample taken as part of their regular follow-up visits. The concentration of the drug (axit
Sponsors
Central European Society for Anticancer Drug Research (CESAR) e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who are being treated with either axitinib or cabozantinib, who have full legal capacity and are linguistically, physically and mentally capable of completing the patient questionnaire independently, and who have provided written informed consent.
Exclusion criteria
Exclusion criteria: Patients with insufficient knowledge of the German language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study objective is to prospectively gain evidence on the potential of a routine TDM to reduce the frequency and severity of adverse drug events compared with the frequency and severity of adverse drug events in historical controls (extracted from literature) in patients receiving oral tumor therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| -To gain insight into the potential of a routinely performed therapeutic drug monitoring to identify (i) the existence of patient subgroups with a particularly high incidence of and/or particularly high severity of adverse drug reactions, and (ii) plasma concentration thresholds that should not be exceeded for acceptable toxicity -To investigate the practicality of the VAMS technology for TDM sample collection -Development and establishment of a nationwide infrastructure for the implementation of TDM for oral anticancer drugs | — |
Countries
Germany
Contacts
Public ContactFenja Klima
Freie Universität Berlin, Institut für Pharmazie, Abteilung Klinische Pharmazie & Biochemie
Outcome results
None listed