An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Patients With Hepatocellular Carcinoma

Inclusion Criteria

Inclusion Criteria

- Unresectable locally advanced or metastatic HCC;

- Histologic confirmation not required if other diagnostic criteria are met;

- No previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer
regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization,
radiofrequency ablation, or other local ablative therapies are permitted if > 6 weeks
of first day of study-defined treatment;

- ECOG PS 0 or 1; Child-Pugh Cirrhotic Status A or B with a score of 7;

- Blood pressure must be well-controlled (≤140/90 mmHg at screening) with or without
antihypertensive medication. Patients must have no history of hypertensive crisis or
hypertensive encephalopathy;

Exclusion Criteria

- Previously received E7050 anti-cmet, or anti-angiogenic therapy (prior
anti-angiogenic therapy is permitted in Phase Ib only);

- Presence of brain metastases, unless the patient has received adequate treatment at
least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids
for at least 4 weeks prior to randomization;

- Palliative radiotherapy is not permitted throughout the study period;

- Active hemoptysis

- Serious non-healing wound, ulcer, or active bone fracture;

- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to commencing study treatment, or anticipation of need for a major surgical
procedure during the course of the study;

- Clinically significant gastrointestinal bleeding (bleeding requiring procedural
intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt
(TIPS) procedure, arterial embolization, topical coagulation therapy) within 6 months
prior to first dose.