Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01003015

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

36 participants

Allocation:

N/A

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 :

Sep 1, 2009

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: BAY73-4506

160 mg BAY73-4506

Outcome Measures

Primary Outcome Measures

Adverse Event Collection [Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Regensburg	Bayern	Germany	93042
2	Frankfurt	Hessen	Germany	60590
3	Essen	Nordrhein-Westfalen	Germany	45122
4	Mainz	Rheinland-Pfalz	Germany	55131
5	Magdeburg	Sachsen-Anhalt	Germany	39112
6	Rozzano	Milano	Italy	20089
7	Bologna		Italy	40138
8	Milano		Italy	20122
9	Milano		Italy	20133
10	Roma		Italy	00168
11	Daegu		Korea, Republic of	700-721
12	Seoul		Korea, Republic of	135-710
13	Barcelona		Spain	08036