Trials / Unknown
UnknownNCT01078311
Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Phase 2 Study of Measurement of Trough Levels of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- South West Sydney Local Health District · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2012-02-01
- Completion
- 2014-02-01
- First posted
- 2010-03-02
- Last updated
- 2010-03-02
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT01078311. Inclusion in this directory is not an endorsement.