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

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2013

Conditions
Carcinoma, Hepatocellular
Interventions
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)

Trial Locations (15)

100

Taipei

736

Tainan City

833

Kaohsiung City

228510

Singapore

258499

Singapore

Unknown

Shatin

Hong Kong

Tainan City

700-721

Junggu

410-769

Goyang-si

602-739

Busan

110-744

Seoul

120-752

Seoul

135-710

Seoul

138-736

Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY