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Information for interested physicians

When and how often should the Therapeutic Drug Monitoring be performed?

In the context of the non-interventional character of the study, the indication for a TDM lies entirely with the treating physician. Since the focus of this study is on reducing the frequency and severity of adverse drug reactions, a TDM is particularly useful in the case of frequent and severe adverse drug reactions, and can for example before a planned dose reduction.

Are there fixed time points at which the Therapeutic Drug Monitoring should be performed?

Since at best steady-state concentrations have been reached before drug concentration determination, the first determination is useful 2-3 days upon the start of treatment with axitinib and 15 days upon the start of treatment with cabozantinib. Due to the use of pharmacometric models for evaluation, blood samples can be obtained at any time as long as the time of blood collection is accurately documented.

How high is the effort in this study for me?

All documentation and blood collection materials are provided and sent to the study sites. The documentation effort is minimal and limited to the completion of one Case Reporting Form per patient visit. The time spent for documentation is no more than 15 minutes for the first appointment and no more than 10 minutes for subsequent appointments.

What is the duration of the study participation per patient?

There is no minimum duration of study participation per patient. The decision for how long a patient participates in the study is solely up to you and the treated patient and is based on the frequency and severity of the adverse drug reactions experienced. The maximum study participation per patient is equal to the total study duration (2 years).

Can TDM be performed for drugs other than axitinib and cabozantinib?

Currently, only patients treated with axitinib or cabozantinib can be recruited for the study. However, our goal is to extend our TDM infrastructure for as many drugs as possible. We would be happy to assess whether we can expand our TDM infrastructure for the drug of your choice. Please contact us via the contact form.