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Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01003015
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : April 3, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: BAY73-4506 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)
Study Start Date : September 2009
Primary Completion Date : November 2010
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY73-4506
160 mg BAY73-4506

Outcome Measures

Primary Outcome Measures :
  1. Adverse Event Collection [ Time Frame: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression ]
  2. Objective response rate [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ]
  3. Disease control rate [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ]
  4. Overall survival [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ]
  5. Trough concentration of Regorafenib and metabolites (for Europe only) [ Time Frame: Cycle 1 Day 15 and Cycle 2 Day 1 ]
  6. Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only) [ Time Frame: Cycle 1 Day 21 to Day 28 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003015

Regensburg, Bayern, Germany, 93042
Frankfurt, Hessen, Germany, 60590
Essen, Nordrhein-Westfalen, Germany, 45122
Mainz, Rheinland-Pfalz, Germany, 55131
Magdeburg, Sachsen-Anhalt, Germany, 39112
Rozzano, Milano, Italy, 20089
Bologna, Italy, 40138
Milano, Italy, 20122
Milano, Italy, 20133
Roma, Italy, 00168
Korea, Republic of
Daegu, Korea, Republic of, 700-721
Seoul, Korea, Republic of, 135-710
Barcelona, Spain, 08036
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01003015     History of Changes
Other Study ID Numbers: 14596
2009-012570-13 ( EudraCT Number )
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Bayer:

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases