Skip to content

Pharmacogenetics of Mitotane

Pharmacogenetics of Mitotane - Pharmacogenetics of Mitotane

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42303
Enrollment
50
Registered
2015-03-18
Start date
2015-03-27
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adrenal cancer adrenal neoplasm

Interventions

None listed

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • No mitotane dose known at the time of plasma concentration measurements. • Simultaneous treatment with chemotherapy.

Design outcomes

Primary

MeasureTime frame
A significant association between one or more SNP(s) on the DMET platform and mitotane clearance, corrected for clinical factors of influence as included in the PK-model.

Secondary

MeasureTime frame
- A significant association between the occurrence of serious adverse events and one or more SNP*s on the DMET platform. - A significant association between the period in weeks from initiation of mitotane therapy until first mitotane concentration >=14mg/L and one or more SNP*s on the DMET platform.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)