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)

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.

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