drugset / Trial / NCT00901901

Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma

NCT00901901

Phase 3 Completed 732 enrolled Bayer
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Timeline

Start
2009-05-21
Primary completion
2012-04-17
Completion
2018-05-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg
Subject Sorafenib Small molecule 400 mg