Status:
COMPLETED
Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01003015
Start Date
September 1 2009
End Date
March 1 2013
Last Update
April 3 2015
Active Locations (13)
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1
Regensburg, Bavaria, Germany, 93042
2
Frankfurt am Main, Hesse, Germany, 60590
3
Essen, North Rhine-Westphalia, Germany, 45122
4
Mainz, Rhineland-Palatinate, Germany, 55131