Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: BAY73-4506

• Registration Number: NCT01003015
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2010-11
• Study Completion: 2013-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY73-4506	-

Primary Outcome Measures

Name	Time	Method
Adverse Event Collection	Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration

Secondary Outcome Measures

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