NCT01204177

Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.

A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	BAY86-9766 MEK Inhibitor + Sorafenib	All patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression)

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-08-01
• Completion: 2013-08-01
• First posted: 2010-09-17
• Last updated: 2013-09-06

Locations

15 sites across 4 countries: Hong Kong, Singapore, South Korea, Taiwan