Pharmacokinetic modeling of mitotane

Completed

• Conditions: adrenocortical carcinoma; cancer of the adrenal cortex; 10001353

• Registration Number: NL-OMON37374
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Treatment with oral mitotane ongoing for > 24 weeks;
- Age > 18 years;
- Able to comply with the protocol;
- Written informed consent;

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are observed mitotane plasma levels, mitotane doses<br /><br>administered and time between mitotane dosing and sampling.<br /><br>These parameters combined with patient characteristics will be used in order to<br /><br>construct a population PK-model using specialized software.<br /><br>Clinical application of these findings may permit selection of an appropriate<br /><br>dosing schedule, in order to more rapidly achieve therapeutic plasma levels. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective: Screen for the influence of patient characteristics on<br /><br>pharmacokinetics of mitotane in patients treated with oral therapy.</p><br>