check_circleStudy Completed
Carcinoma, Hepatocellular
Bayer Identifier:
14596
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
36Trial Dates
September 2009 - March 2013Phase
Phase 2Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsklinikum Essen | Essen, 45122, Germany |
Completed | Klinikum der Johann Wolfgang Goethe Universität Frankfurt | Frankfurt, 60590, Germany |
Completed | Universitätsklinikum Regensburg | Regensburg, 93042, Germany |
Completed | IRCCS Istituto Nazionale Tumori | Milano, 20133, Italy |
Completed | A.O.U. di Bologna - Policlinico S.Orsola-Malpighi | Bologna, 40138, Italy |
Completed | Università Cattolica del Sacro Cuore | Roma, 00168, Italy |
Completed | IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico | Milano, 20122, Italy |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Samsung Medical Center | Seoul, 135-710, Korea, Republic Of |
Completed | Kyungpook National University Hospital | Daegu, 700-721, Korea, Republic Of |
Completed | Johannes-Gutenberg-Universität Mainz | Mainz, 55131, Germany |
Completed | Universitätsklinikum Otto-von Guericke - Magdeburg | Magdeburg, 39112, Germany |
Completed | IRCCS Istituto Clinico Humanitas - ICH | Rozzano, 20089, Italy |
Primary Outcome
- Adverse Event Collectiondate_rangeTime Frame:Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administrationenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Time to progressiondate_rangeTime Frame:Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progressionenhanced_encryptionnoSafety Issue:
- Objective response ratedate_rangeTime Frame:Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progressionenhanced_encryptionnoSafety Issue:
- Disease control ratedate_rangeTime Frame:Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progressionenhanced_encryptionnoSafety Issue:
- Overall survivaldate_rangeTime Frame:Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progressionenhanced_encryptionnoSafety Issue:
- Trough concentration of Regorafenib and metabolites (for Europe only)date_rangeTime Frame:Cycle 1 Day 15 and Cycle 2 Day 1enhanced_encryptionnoSafety Issue:
- Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only)date_rangeTime Frame:Cycle 1 Day 21 to Day 28enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1