Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01003015
First received: October 2, 2009
Last updated: March 31, 2014
Last verified: March 2014
  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.


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003015

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

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov 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:
HCC
Safety
BAY73-4506

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

ClinicalTrials.gov processed this record on October 20, 2014