A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
Inclusion Criteria:
- Male or Female age >/= 18 years of age
- Life expectancy >/= 12 weeks
- Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or
metastatic
- Liver function status of Child-Pugh class A. Child-Pugh status based on clinical
findings and laboratory results during the screening period
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Patients must have at least one naïve (not previously treated by locoregional
therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ,
basal cell carcinoma, superficial bladder tumors.
- History of cardiac disease: Congestive heart failure (CHF), unstable angina,
arrhythmias, Uncontrolled hypertension
- Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
- Renal failure requiring hemo- or peritoneal dialysis
- Known human immunodeficiency virus (HIV) infection
- Known history or symptomatic metastatic brain or meningeal tumors
- History of organ allograft.
- History of interstitial lung disease (ILD).
- Excluded previous therapies and medications:
- Prior use of systemic anti-cancer treatment for HCC including cytotoxic
chemotherapy, targeted agents, or any experimental therapy
- Radiotherapy within 4 weeks prior to start of study treatment
- Any other investigational agents within 4 weeks from the first dose of study
treatment
- Major surgery within 4 weeks of start of study
- Concomitant use of strong inhibitors and strong inducers of CYP3A4