Population pharmacokinetics and pharmacodynamics of sorafenib in hepatocellular carcinoma patients with Child Pugh B liver cirrhosis

Population pharmacokinetics and pharmacodynamics of sorafenib in hepatocellular carcinoma patients with Child Pugh B liver cirrhosis - Sorafenib pharmacokinetics in Child Pugh B liver cirrhosis (SORBE)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44524

Enrollment

Registered

2014-05-15

Start date

2014-07-16

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

hepatocellular carcinoma liver cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: advanced hepatocelllar carcinoma (HCC) - BCLC stage C Child Pugh(CP)-B liver cirrhosis (CP-B score 7 or 8)

Exclusion criteria

Exclusion criteria: Child Pugh-B9 liver cirrhosis Child Pugh-C liver cirrhosis Concurrent antitumoral treatment for HCC or other malignancies

Design outcomes

Primary

Measure	Time frame
1. Exposure and intra- and inter-patient variability in exposure to sorafenib and its metabolites 2. Identification of predictive factors for sorafenib exposure, i.e. bilirubin, CYP3A4 activity	—

Secondary

Measure	Time frame
3. Correlation between sorafenib exposure and adverse events and progression free survival 4. Difference in exposure to 5 CYP probe drugs following administration of an oral cocktail of these agents after 4 weeks of sorafenib treatment in comparison with exposure to these cocktail probe drugs before initiation of sorafenib (substudy in 15 patients)	—

Countries

Netherlands

Outcome results