Exploratory Open Label Dose-escalation Phase Ib Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO5323441, Administered Intravenously, in Combination With Sorafenib (Nexavar®), in Patients With Advanced or Metastatic and/or Unresectable Hepatocellular Carcinoma
Inclusion Criteria:
- Adult patients >/= 21 years of age
- Advanced or metastatic and/or unresectable hepatocellular carcinoma
- At least 1 measurable lesion according to RECIST criteria
- Primary tumor in situ (Expansion Cohort Part I, Part II)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Prior systemic treatment for metastatic hepatocellular carcinoma or patients who had
tumor removed (Expansion Cohort Part I, Part II)
- Major surgery within previous 4 weeks or planned major surgical procedure during
course of study
- Radiation therapy within 28 days prior to start of study treatment
- Serious non-healing wound, ulcer ore bone fracture
- History of uncontrolled seizures or encephalopathy within the last 6 months
- Current central nervous system (CNS) metastases or spinal cord compression
- History of gastrointestinal perforation or esophageal/gastric bleeding within 6
months prior to study enrollment
- History of another primary malignancy and off treatment for = 3 years, except for
non-melanoma skin cancer and carcinoma in situ of the cervix
- Patients with prior liver transplant
- Inadequately controlled hypertension or prior history of hypertensive crisis or
hypertensive encephalopathy
- Active bleeding diathesis