check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

13414

ClinicalTrials.gov Identifier:

NCT00812175

EudraCT Number:

Not Available

EU CT Number:

Not Available
Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with Sorafenib

Trial purpose

In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

Key Participants Requirements

Sex

Both

Age

18 - N/A


  • - Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI.
    - Patients must have signed an informed consent form
    - Patients must have a life expectancy of at least 8 weeks
  • - Exclusion criteria must follow the approved local product information

Trial summary

Enrollment Goal
3371
Trial Dates
January 2009 - April 2012
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France
Completed
Many Locations, Canada
Completed
Many Locations, Mexico
Completed
Many Locations, Sweden
Withdrawn
Many Locations, South Africa
Completed
Many Locations, Czech Republic
Completed
Many Locations, Israel
Completed
Many Locations, Portugal
Completed
Many Locations, Slovakia
Completed
Many Locations, Ukraine
Completed
Many Locations, China
Completed
Many Locations, Indonesia
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, India
Completed
Many Locations, Hong Kong
Completed
Many Locations, Malaysia
Completed
Many Locations, Croatia
Completed
Many Locations, Romania
Withdrawn
Many Locations, Morocco
Withdrawn
Many Locations, Kuwait
Completed
Many Locations, Japan
Completed
Many Locations, Italy
Completed
Many Locations, Spain
Completed
Many Locations, Norway
Completed
Many Locations, Hungary
Withdrawn
Many Locations, Turkey
Completed
Many Locations, Colombia
Completed
Many Locations, Greece
Completed
Many Locations, Russia
Completed
Many Locations, Venezuela
Completed
Many Locations, Philippines
Completed
Many Locations, Singapore
Completed
Many Locations, Uruguay
Withdrawn
Many Locations, Slovenia
Completed
Many Locations, Pakistan
Withdrawn
Many Locations, Egypt
Withdrawn
Many Locations, Saudi Arabia
Completed
Many Locations, United Arab Emirates
Completed
Many Locations, Finland
Completed
Many Locations, Kazakhstan
Withdrawn
Many Locations, Oman
Withdrawn
Many Locations, Bahrain
Completed
Many Locations, Qatar
Completed
Many Locations, Syria
Completed
Many Locations, Vietnam
Completed
Many Locations, Libya
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, China
Completed
Many Locations, Finland
Completed
Many Locations, Thailand
Withdrawn
Many Locations, Bosnia And Herzegovina
Completed
Many Locations, Kazakhstan
Completed
Many Locations, United States

Primary Outcome

  • The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions
    date_rangeTime Frame:
    at each follow-up visit, every 2-4 months on average
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar
    date_rangeTime Frame:
    at every visit, roughly every 2-4 months
    enhanced_encryption
    Safety Issue:
    No
  • The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables
    date_rangeTime Frame:
    at every visit, roughly every 2-4 months
    enhanced_encryption
    Safety Issue:
    No
  • To evaluate the methods of patient evaluation, diagnosis and follow up
    date_rangeTime Frame:
    at every visit, roughly every 2-4 months
    enhanced_encryption
    Safety Issue:
    No
  • To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome
    date_rangeTime Frame:
    at every visit, roughly every 2-4 months
    enhanced_encryption
    Safety Issue:
    No
  • To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions
    date_rangeTime Frame:
    at every visit, roughly every 2-4 months
    enhanced_encryption
    Safety Issue:
    No
  • Reports of adverse events
    date_rangeTime Frame:
    at every visit, roughly every 2-4 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with Sorafenib
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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