Population pharmacokinetics and pharmacodynamics of sorafenib in hepatocellular carcinoma patients with Child Pugh B liver cirrhosis
Completed
- Conditions
- hepatocellular carcinomaliver cancer1001965410019815
- Registration Number
- NL-OMON44524
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
advanced hepatocelllar carcinoma (HCC) - BCLC stage C
Child Pugh(CP)-B liver cirrhosis (CP-B score 7 or 8)
Exclusion Criteria
Child Pugh-B9 liver cirrhosis
Child Pugh-C liver cirrhosis
Concurrent antitumoral treatment for HCC or other malignancies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Exposure and intra- and inter-patient variability in exposure to sorafenib<br /><br>and its metabolites<br /><br>2. Identification of predictive factors for sorafenib exposure, i.e. bilirubin,<br /><br>CYP3A4 activity</p><br>
- Secondary Outcome Measures
Name Time Method <p>3. Correlation between sorafenib exposure and adverse events and progression<br /><br>free survival<br /><br>4. Difference in exposure to 5 CYP probe drugs following administration of an<br /><br>oral cocktail of these agents after 4 weeks of sorafenib treatment in<br /><br>comparison with exposure to these cocktail probe drugs before initiation of<br /><br>sorafenib (substudy in 15 patients)</p><br>