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Study synopsis

Study title:

Non-interventional study of therapeutic drug monitoring (TDM) in patients with renal cell carcinoma and to investigate the practicality of VAMS technology for sample collection (ON-TARGET).


Renal cell carcinoma, treatment with axitinib or cabozantinib

Study design:

Prospective, multi-centre, non-interventional study

Primary study objective:

The primary study objective is to prospectively gain evidence on the potential of 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 in patients receiving oral tumor therapy.

Secondary study objectives:

To gain insight into the potential of routine TDM for:

  • the existence of patient subgroups that experience particularly frequent and/or serious adverse drug events
  • Plasma concentration thresholds that should not be exceeded for acceptable toxicity
  • Investigation of the practicability of the VAMS technology for TDM sample collection
  • Development and establishment of a nationwide TDM infrastructure

Study centres:

Both hospitals and outpatient oncology practices that have established TDM as a therapeutic standard can participate as study centers

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:

Patients with insufficient knowledge of the German language.

Study duration:

2.5 years