Improving bio-availability of the expensive oral oncolytic drug abiraterone by food intake
- Conditions
- metastatic castration resistent prostate carinomaprostate cancer10038597
- Registration Number
- NL-OMON45784
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
-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
•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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The aim of this part of the study is to determine the equivalent reduced dose<br /><br>of abirateron when taken with a continental<br /><br>breakfast compared to the registered intake of abirateron (e.g. 1000 mg OD<br /><br>without food)</p><br>
- Secondary Outcome Measures
Name Time Method <p>To explore, quantify and describe patients preference; abirateron intake with<br /><br>or without food.</p><br>