The main objective of this study is to construct a population-pharmacokinetic model, in order to evaluate the influence of patient characteristics on the pharmacokinetics of mitotane in patients treated with this oral therapy.
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary Objective: Screen for the influence of patient characteristics on
pharmacokinetics of mitotane in patients treated with oral therapy.
Background summary
Very little information is known about the pharmacokinetics of mitotane.
Adequate dosing is important, as the drug is only proven to be effective when a
plasma level of 14 mg/L is maintained. Current dosing regimes are formulated
based on expert opinion. Differences in plasma levels between patients are thus
far poorly understood.
Study objective
The main objective of this study is to construct a population-pharmacokinetic
model, in order to evaluate the influence of patient characteristics on the
pharmacokinetics of mitotane in patients treated with this oral therapy.
Study design
This study was designed as an observational study.
Study burden and risks
Participation in the study requires one hospital visit, time spent at the
hospital is approximately 8 hours. Ten plasma samples of 5mL each will be
collected, from which one sample will be stored for future use in a
pharmacogenetic study. Oral treatment with mitotane will be administered in
accordance with patient*s own dosing schedule. Risks associated with
participation are related to venapuncture. There will be no individual benefit
associated with participation.
Ds. Th. Fliednerstraat 1
Eindhoven 5600 PD
NL
Ds. Th. Fliednerstraat 1
Eindhoven 5600 PD
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-006284-22-NL |
| CCMO | NL39880.015.12 |