NCT00901901

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

A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 732 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

European quality of life scale (5 dimensions) (EQ-5D)

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg twice daily
DRUG	Erlotinib (Tarceva)	Erlotinib 150 mg once daily
DRUG	Placebo	Matching erlotinib placebo 150 mg once daily

Timeline

• Start date: 2009-05-21
• Primary completion: 2012-04-17
• Completion: 2018-05-23
• First posted: 2009-05-14
• Last updated: 2019-05-30
• Results posted: 2013-09-30

Locations

127 sites across 26 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Greece, Hong Kong, Israel, Italy, New Zealand, Peru, Poland, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study