Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

April 2, 2015 updated by: Bayer

An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: BAY73-4506
160 mg BAY73-4506

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event Collection
Time Frame: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration
Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14596
  • 2009-012570-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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