check_circleStudy Completed

Liver Neoplasms

Bayer Identifier:

19244

ClinicalTrials.gov Identifier:

NCT03289273

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

All

Age

NaN - N/A
  • - Patients with confirmed diagnosis of unresectable HCC
    - Physician-initiated decision to treat with regorafenib (prior to study enrollment)

  • - Participation in an investigational program with interventions outside of routine clinical practice
    - Past treatment with regorafenib

Trial summary

Enrollment Goal
1010
Trial Dates
September 2017 - June 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Mercy Medical CenterBaltimore, 21202, United States
Completed
Many locationsMany locations, Japan
Completed
Many locationsMany locations, France
Completed
Many locationsMany locations, Italy
Completed
Many locationsMany locations, Spain
Withdrawn
Many locationsMany locations, Mexico
Completed
Many locationsMany locations, Sweden
Completed
Many locationsMany locations, Denmark
Completed
Many locationsMany locations, Argentina
Completed
Many locationsMany locations, Austria
Completed
Many locationsMany locations, Turkey
Completed
Many locationsMany locations, Russia
Completed
Many locationsMany locations, China
Completed
Many locationsMany locations, Korea, Republic Of
Withdrawn
Many locationsMany locations, India
Completed
Many locationsMany locations, Taiwan
Completed
Many locationsMany locations, Thailand
Completed
Many locationsMany locations, Egypt
Completed
Many locationsMany locations, Saudi Arabia
Withdrawn
Many locationsMany locations, Oman
Withdrawn
Many locationsMany locations, Kazakhstan
Withdrawn
Many locationsMany locations, Albania
Withdrawn
Many locationsMany locations, Lebanon
Withdrawn
Many locationsMany locations, United Arab Emirates
Withdrawn
Many locationsMany locations, Luxembourg
Withdrawn
Many locationsMany locations, Algeria
Completed
Many locationsMany locations, Greece
Completed
Henry Ford Health SystemDetroit, 48202, United States
Completed
Many locationsMany locations, Belgium
Completed
Many locationsMany locations, Netherlands
Withdrawn
Many locationsMany locations, Brazil
Completed
Einstein Medical CenterPhiladelphia, 19141, United States
Completed
St. Joseph´s Hospital and Medical CenterPhoenix, 85013, United States
Completed
University of Florida HealthGainsville, 32610, United States
Completed
Corporal Michael J. Crescenz VA Medical CenterPhiladelphia, 19104, United States
Completed
University of MichiganAnn Arbor, 48109, United States
Completed
University Medical CenterNew Orleans, 70112, United States
Completed
UT Southwestern Medical CenterDallas, 75390, United States
Completed
University of Louisville - Clinical Trials UnitLouisville, 40202, United States
Completed
Many locationsMany locations, Canada
Completed
Rutgers UniversityNewark, 07101-1709, United States
Completed
Mayo ClinicRochester, 55905, United States
Completed
University of CincinattiCincinatti, 45267, United States
Completed
Banner MD Anderson Cancer CenterGilbert, 85234, United States
Withdrawn
Scripps HealthLa Jolla, 92037, United States
Withdrawn
Westchester Medical CenterHawthorne, 10532, United States
Withdrawn
McGuire VA Medical CenterRichmond, 23226, United States
Withdrawn
Georgetown University Hospital, Lombardi Cancer CenterWashington, 20007, United States
Withdrawn
Lahey Hospital & Medical CenterBurlington, 01805, United States
Withdrawn
Summit Cancer CenterSavannah, 31405, United States
Withdrawn
Methodist Healthcare, University HospitalMemphis, 38104, United States
Withdrawn
Northwestern MedicineChicago, 60611, United States
Withdrawn
Compassionate Care Research Group, Inc.Fountain Valley, 92708, United States
Completed
C.R.Wood Cancer Center, Glen Falls HospitalGlen Falls, 12801, United States
Completed
Roswell Park Cancer InstituteBuffalo, 14263, United States
Completed
MD Anderson Cancer CenterHouston, 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-up
    date_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 documented
    date_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 progression
    date_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 standard
    date_rangeTime Frame:
    Up to 24 months
  • Duration of regorafenib treatment
    Duration 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

REFINE: Regorafenib observational study in hepatocellular carcinoma
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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