Carcinoma, Hepatocellular
Conditions
Keywords
HCC, Safety, BAY73-4506
Brief summary
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.
Interventions
DRUGBAY73-4506
160 mg BAY73-4506
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event Collection | Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Time to progression | Every 6 weeks during treatment 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 |
| Overall survival | Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression |
Countries
Germany, Italy, South Korea, Spain
Outcome results
None listed