Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.

Official Title
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An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Drug: BAY73-4506


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 sorafenib therapy) 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 BAY73-4506. ECOG PS of 0 or 1. Adequate bone marrow, liver and renal function Exclusion Criteria: 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 medication. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: BAY73-4506<br>* 160 mg BAY73-4506<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Collection |  | Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression | 
| Objective response rate |  | Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression | 
| Disease control rate |  | Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression | 
| Overall survival |  | Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression | 
| Trough concentration of Regorafenib and metabolites (for Europe only) |  | Cycle 1 Day 15 and Cycle 2 Day 1 | 
| Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only) |  | Cycle 1 Day 21 to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, Safety, BAY73-4506