An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)
- Male or female patients aged equal or above 18 years.
- BCLC stage Category A, B or C that cannot benefit from treatments of established
efficacy with higher priority such as resection, liver transplantation, local
ablation, chemoembolization or systemic sorafenib.
- Liver function status Child-Pugh class A.
- Failure to prior treatment with sorafenib (defined as radiological progression under
- Local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial
embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol
injection, or cryoablation) must have been completed = 4 weeks before first dose of
- ECOG PS of 0 or 1.
- Adequate bone marrow, liver and renal function
- Prior systemic treatment with molecular targeted agents for HCC, except sorafenib.
Prior chemotherapy treatment is allowed.
- Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at
screening to confirm the absence of central nervous system [CNS] disease if patient
has symptoms suggestive or consistent with CNS disease).
- Congestive heart failure NYHA>/= class 2
- Unstable angina (angina symptoms at rest, new onset angina within the last 3 months)
or myocardial infarction (MI) within the past 6 months before start of study
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are
- Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure
> 90 mmHg despite optimal medical management).
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident
(including transient ischemic attacks), deep vein thrombosis or pulmonary embolism
within 6 months before the start of study treatment.