Trial Condition(s):
Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
14596
Not Available
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.
- 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
- 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.
Locations | |
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Locations Universitätsklinikum Essen Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60590 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Regensburg Regensburg, Germany, 93042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Istituto Nazionale Tumori Milano, Italy, 20133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna - Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università Cattolica del Sacro Cuore Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyungpook National University Hospital Daegu, South Korea, 700-721 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Otto-von Guericke - Magdeburg Magdeburg, Germany, 39112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Istituto Clinico Humanitas - ICH Rozzano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
An uncontrolled open label multicenter phase II safety study of BAY73-4506 in patients with hepatocellular carcinoma (HCC)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1