Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: October 2, 2009
Last updated: March 31, 2014
Last verified: March 2014

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 Intervention Phase
Carcinoma, Hepatocellular
Drug: BAY73-4506
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse Event Collection [ Time Frame: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ] [ Designated as safety issue: No ]
  • Trough concentration of Regorafenib and metabolites (for Europe only) [ Time Frame: Cycle 1 Day 15 and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
  • Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only) [ Time Frame: Cycle 1 Day 21 to Day 28 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2009
Study Completion Date: March 2013
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY73-4506
160 mg BAY73-4506


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: 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 Identifier: NCT01003015     History of Changes
Other Study ID Numbers: 14596, 2009-012570-13
Study First Received: October 2, 2009
Last Updated: March 31, 2014
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizin-produkte (BfArM)
Italy: Agenzia Italiana del Farmaco (AIFA)
Spain:Agencia Española de Medicamentos y Productos Sanitarios (AGEMED)
Korea: Korea Food & Drug Administration (KFDA)

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 processed this record on April 16, 2014