adrenocortical carcinoma cancer of the adrenal cortex
Conditions
Interventions
None listed
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Treatment with oral mitotane ongoing for > 24 weeks; - Age > 18 years; - Able to comply with the protocol; - Written informed consent;
Exclusion criteria
Exclusion criteria: - Any severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are observed mitotane plasma levels, mitotane doses administered and time between mitotane dosing and sampling. These parameters combined with patient characteristics will be used in order to construct a population PK-model using specialized software. Clinical application of these findings may permit selection of an appropriate dosing schedule, in order to more rapidly achieve therapeutic plasma levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective: Screen for the influence of patient characteristics on pharmacokinetics of mitotane in patients treated with oral therapy. | — |
Countries
Netherlands
Outcome results
None listed