Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

NCT ID: NCT01003015

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-03-31

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

BAY73-4506

Intervention Type: DRUG

160 mg BAY73-4506

Interventions

BAY73-4506

160 mg BAY73-4506

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Regensburg, Bavaria, Germany

Frankfurt am Main, Hesse, Germany

Essen, North Rhine-Westphalia, Germany

Mainz, Rhineland-Palatinate, Germany

Magdeburg, Saxony-Anhalt, Germany

Rozzano, Milano, Italy

Bologna, , Italy

Milan, , Italy

Milan, , Italy

Roma, , Italy

Daegu, , South Korea

Seoul, , South Korea

Barcelona, Barcelona, Spain

Countries

Germany; Italy; South Korea; Spain

References

Bruix J, Tak WY, Gasbarrini A, Santoro A, Colombo M, Lim HY, Mazzaferro V, Wiest R, Reig M, Wagner A, Bolondi L. Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study. Eur J Cancer. 2013 Nov;49(16):3412-9. doi: 10.1016/j.ejca.2013.05.028. Epub 2013 Jun 25.

Reference Type: RESULT

PMID: 23809766 (View on PubMed)

Other Identifiers

2009-012570-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14596

Identifier Type: -

Identifier Source: org_study_id