Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)
2 other identifiers
interventional
36
4 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2009
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 3, 2015
April 1, 2015
1.2 years
October 2, 2009
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Event Collection
Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (13)
Unknown Facility
Regensburg, Bavaria, 93042, Germany
Unknown Facility
Frankfurt am Main, Hesse, 60590, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45122, Germany
Unknown Facility
Mainz, Rhineland-Palatinate, 55131, Germany
Unknown Facility
Magdeburg, Saxony-Anhalt, 39112, Germany
Unknown Facility
Rozzano, Milano, 20089, Italy
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Milan, 20122, Italy
Unknown Facility
Milan, 20133, Italy
Unknown Facility
Roma, 00168, Italy
Unknown Facility
Daegu, 700-721, South Korea
Unknown Facility
Seoul, 135-710, South Korea
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Related 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 J Cancer. 2013 Nov;49(16):3412-9. doi: 10.1016/j.ejca.2013.05.028. Epub 2013 Jun 25.
PMID: 23809766RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 28, 2009
Study Start
September 1, 2009
Primary Completion
November 1, 2010
Study Completion
March 1, 2013
Last Updated
April 3, 2015
Record last verified: 2015-04