Trial Condition(s):

Carcinoma, Hepatocellular

Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

Bayer Identifier:

14596

ClinicalTrials.gov Identifier:

NCT01003015

EudraCT Number:

2009-012570-13

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
36
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Universitätsklinikum Regensburg

Regensburg, Germany, 93042

Status
Completed
 
Locations

IRCCS Istituto Nazionale Tumori

Milano, Italy, 20133

Status
Completed
 
Locations

A.O.U. di Bologna - Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Status
Completed
 
Locations

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Kyungpook National University Hospital

Daegu, South Korea, 700-721

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

Universitätsklinikum Otto-von Guericke - Magdeburg

Magdeburg, Germany, 39112

Status
Completed
 
Locations

IRCCS Istituto Clinico Humanitas - ICH

Rozzano, Italy, 20089

Status
Completed
 

Trial Design