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Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma — DOSE-HEP  

Hepatocellular Cancer Clinical Trial

Official title:
Phase 2 Study of Measurement of Trough Levels of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Summary

Sorafenib improves overall survival and progression free survival in advanced hepatocellular carcinoma. Wide interindividual pharmacokinetic variability was observed. Data from early phase trials in solid tumours showed trough sorafenib levels were associated with incidence of skin rash and hypertension. Rash, hypertension and higher trough levels were moderately predictive of progression free survival.The trough level of sorafenib may be predictive of survival and response in patients treated with sorafenib for advanced hepatocellular carcinoma.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01078311
Study type Observational
Source South West Sydney Local Health District
Contact Mark Wong, MBBS, FRACP
Phone 61298455200
Email Mark.Wong@swahs.health.nsw.gov.au
Status Recruiting
Phase N/A
Start date February 2010
Completion date February 2014
View Details
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