metastatic castration resistent prostate carinoma prostate cancer
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.;->= 18 year old men who use abiraterone ;-Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ;-Feasible to collect blood samples from
Exclusion criteria
Exclusion criteria: •Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product ;•Malabsorption syndrome.;•Major resection of the stomach or small bowel.;•Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject*s safety, provision of informed consent, or compliance to study procedures. ;•Unable or unwilling to discontinue use of prohibited medications listed in for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of day 1 and for the duration of the study.;•Concurrent use of other substances known or likely to interfere with the pharmacokinetics of abiraterone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this part of the study is to determine the equivalent reduced dose of abirateron when taken with a continental breakfast compared to the registered intake of abirateron (e.g. 1000 mg OD without food) | — |
Secondary
| Measure | Time frame |
|---|---|
| To explore, quantify and describe patients preference; abirateron intake with or without food. | — |
Countries
Netherlands
Outcome results
None listed