Pharmacogenetics of Mitotane
Completed
- Conditions
- adrenal canceradrenal neoplasm10001353
- Registration Number
- NL-OMON42303
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
• Patients >=18 years.
• Histological proven ACC.
• The patient has been treated with mitotane > 24 weeks.
• Preferably >= 1 or more mitotane measurements >= 14mg/L in the two months prior to inclusion.
• Informed consent through the ENS@T database and/or
• Informed consent if patients will be approached separately for the donation of one EDTA of blood
Exclusion Criteria
• No mitotane dose known at the time of plasma concentration measurements.
• Simultaneous treatment with chemotherapy.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A significant association between one or more SNP(s) on the DMET platform and<br /><br>mitotane clearance, corrected for clinical factors of influence as included in<br /><br>the PK-model.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- A significant association between the occurrence of serious adverse events<br /><br>and one or more SNP*s on the DMET platform.<br /><br>- A significant association between the period in weeks from initiation of<br /><br>mitotane therapy until first mitotane concentration >=14mg/L and one or more<br /><br>SNP*s on the DMET platform. </p><br>