check_circleStudy Completed

Carcinoma, Hepatocellular

Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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.

Trial summary

Enrollment Goal
36
Trial Dates
September 2009 - March 2013
Phase
Phase 2
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60590, Germany
Completed
Universitätsklinikum RegensburgRegensburg, 93042, Germany
Completed
IRCCS Istituto Nazionale TumoriMilano, 20133, Italy
Completed
A.O.U. di Bologna - Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Completed
Università Cattolica del Sacro CuoreRoma, 00168, Italy
Completed
IRCCS Fondazione Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Kyungpook National University HospitalDaegu, 700-721, Korea, Republic Of
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Completed
Universitätsklinikum Otto-von Guericke - MagdeburgMagdeburg, 39112, Germany
Completed
IRCCS Istituto Clinico Humanitas - ICHRozzano, 20089, Italy

Primary Outcome

  • Adverse Event Collection
    date_rangeTime Frame:
    Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Time to progression
    date_rangeTime Frame:
    Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression
    enhanced_encryption
    Safety Issue:
    no
  • Objective response rate
    date_rangeTime Frame:
    Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
    enhanced_encryption
    Safety Issue:
    no
  • Disease control rate
    date_rangeTime Frame:
    Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
    enhanced_encryption
    Safety Issue:
    no
  • Overall survival
    date_rangeTime Frame:
    Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
    enhanced_encryption
    Safety Issue:
    no
  • Trough concentration of Regorafenib and metabolites (for Europe only)
    date_rangeTime Frame:
    Cycle 1 Day 15 and Cycle 2 Day 1
    enhanced_encryption
    Safety Issue:
    no
  • Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only)
    date_rangeTime Frame:
    Cycle 1 Day 21 to Day 28
    enhanced_encryption
    Safety Issue:
    no

Trial design

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