Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003015
• Other study ID #: 14596
• Secondary ID: 2009-012570-13
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2009
• Last updated: April 2, 2015
• Start date: September 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• 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)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2013
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• BAY73-4506
160 mg BAY73-4506

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  Italy,  Korea, Republic of,  Spain, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Collection		Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration	Yes
Secondary	Time to progression		Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression	No
Secondary	Objective response rate		Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression	No
Secondary	Disease control rate		Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression	No
Secondary	Overall survival		Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression	No
Secondary	Trough concentration of Regorafenib and metabolites (for Europe only)		Cycle 1 Day 15 and Cycle 2 Day 1	No
Secondary	Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only)		Cycle 1 Day 21 to Day 28	No

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