check_circleStudy Completed
Liver Neoplasms
Bayer Identifier:
19244
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
Trial purpose
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
Key Participants Requirements
Sex
AllAge
NaN - N/ATrial summary
Enrollment Goal
1010Trial Dates
September 2017 - June 2022Phase
Phase 4Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mercy Medical Center | Baltimore, 21202, United States |
Completed | Many locations | Many locations, Japan |
Completed | Many locations | Many locations, France |
Completed | Many locations | Many locations, Italy |
Completed | Many locations | Many locations, Spain |
Withdrawn | Many locations | Many locations, Mexico |
Completed | Many locations | Many locations, Sweden |
Completed | Many locations | Many locations, Denmark |
Completed | Many locations | Many locations, Argentina |
Completed | Many locations | Many locations, Austria |
Completed | Many locations | Many locations, Turkey |
Completed | Many locations | Many locations, Russia |
Completed | Many locations | Many locations, China |
Completed | Many locations | Many locations, Korea, Republic Of |
Withdrawn | Many locations | Many locations, India |
Completed | Many locations | Many locations, Taiwan |
Completed | Many locations | Many locations, Thailand |
Completed | Many locations | Many locations, Egypt |
Completed | Many locations | Many locations, Saudi Arabia |
Withdrawn | Many locations | Many locations, Oman |
Withdrawn | Many locations | Many locations, Kazakhstan |
Withdrawn | Many locations | Many locations, Albania |
Withdrawn | Many locations | Many locations, Lebanon |
Withdrawn | Many locations | Many locations, United Arab Emirates |
Withdrawn | Many locations | Many locations, Luxembourg |
Withdrawn | Many locations | Many locations, Algeria |
Completed | Many locations | Many locations, Greece |
Completed | Henry Ford Health System | Detroit, 48202, United States |
Completed | Many locations | Many locations, Belgium |
Completed | Many locations | Many locations, Netherlands |
Withdrawn | Many locations | Many locations, Brazil |
Completed | Einstein Medical Center | Philadelphia, 19141, United States |
Completed | St. Joseph´s Hospital and Medical Center | Phoenix, 85013, United States |
Completed | University of Florida Health | Gainsville, 32610, United States |
Completed | Corporal Michael J. Crescenz VA Medical Center | Philadelphia, 19104, United States |
Completed | University of Michigan | Ann Arbor, 48109, United States |
Completed | University Medical Center | New Orleans, 70112, United States |
Completed | UT Southwestern Medical Center | Dallas, 75390, United States |
Completed | University of Louisville - Clinical Trials Unit | Louisville, 40202, United States |
Completed | Many locations | Many locations, Canada |
Completed | Rutgers University | Newark, 07101-1709, United States |
Completed | Mayo Clinic | Rochester, 55905, United States |
Completed | University of Cincinatti | Cincinatti, 45267, United States |
Completed | Banner MD Anderson Cancer Center | Gilbert, 85234, United States |
Withdrawn | Scripps Health | La Jolla, 92037, United States |
Withdrawn | Westchester Medical Center | Hawthorne, 10532, United States |
Withdrawn | McGuire VA Medical Center | Richmond, 23226, United States |
Withdrawn | Georgetown University Hospital, Lombardi Cancer Center | Washington, 20007, United States |
Withdrawn | Lahey Hospital & Medical Center | Burlington, 01805, United States |
Withdrawn | Summit Cancer Center | Savannah, 31405, United States |
Withdrawn | Methodist Healthcare, University Hospital | Memphis, 38104, United States |
Withdrawn | Northwestern Medicine | Chicago, 60611, United States |
Withdrawn | Compassionate Care Research Group, Inc. | Fountain Valley, 92708, United States |
Completed | C.R.Wood Cancer Center, Glen Falls Hospital | Glen Falls, 12801, United States |
Completed | Roswell Park Cancer Institute | Buffalo, 14263, United States |
Completed | MD Anderson Cancer Center | Houston, 77030, United States |
Primary Outcome
- Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation)The primary endpoint is the safety of regorafenib in patients with uHCC, defined as the frequency of documented TEAEs, including serious adverse events (SAEs). Safety will be assessed in all patients who receive at least one dose of regorafenib regardless of prior treatment.date_rangeTime Frame:Up to 24 months
Secondary Outcome
- Overall survival (OS)Overall survival (OS) is defined as the time (days) from the start of regorafenib treatment to the date of death, due to any reason. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-update_rangeTime Frame:Up to 24 months
- Progression-free survival (PFS)Progression-free survival (PFS) is defined as the time (days) from the start of regorafenib treatment to the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documenteddate_rangeTime Frame:Up to 24 months
- Time to progression (TTP)Time to progression (TTP) is defined as the time (days) from the start of regorafenib treatment to the first documented disease progressiondate_rangeTime Frame:Up to 24 months
- Best overall tumor response (ORR)Best overall tumor response (ORR) will be defined according to investigator-assessed data according to local standarddate_rangeTime Frame:Up to 24 months
- Duration of regorafenib treatmentDuration of regorafenib treatment, defined by the time interval from the start of regorafenib treatment to the day of permanent discontinuation of regorafenib (including death)date_rangeTime Frame:Up to 24 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A