stop_circleTerminated/Withdrawn

Carcinoma, Hepatocellular

Bayer Identifier:

14611

ClinicalTrials.gov Identifier:

NCT01191385

EudraCT Number:

Not Available

EU CT Number:

Not Available
GIDEON Non-Nexavar Arm - HCC patients who are treated with any therapy other than Nexavar at individual study start

Trial purpose

This study is an international prospective, open-label, multi-center, non-interventional study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment. All patients will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the study. Detailed information concerning the past medical/surgical history, performance status, methods of diagnosis and staging, etc. of patients with HCC will be collected, and practice patterns of the physicians involved in the care of patients with HCC under real-life conditions will be evaluated.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Outpatients with histologically/cytologically documented or radiographically diagnosed HCC in whom a decision to treat with sorafenib has not been made at this time. Radiographic diagnosis 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

  • - Patients in whom a decision to treat with sorafenib is made at time of study start
    - Patients who have received sorafenib in the past or are currently treated with sorafenib
    - Hospice patients

Trial summary

Enrollment Goal
0
Trial Dates
November 2010 - December 2013
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States
Terminated
Many Locations, United States

Primary Outcome

  • Determination of ‘real-life’ practice patterns of physicians involved in the care of patients with HCC (collection of data on treatments prescribed as well as demographic data and data on the entire medical history)
    date_rangeTime Frame:
    up to 3,3 years
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of patient demographics, disease characteristics, methods of patient evaluation, diagnosis and follow-up of patients with HCC, regionally and globally (collection of data on demographics, medical history, diagnostic measurements, follow-up)
    date_rangeTime Frame:
    up to 3,3 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Evaluation of natural course and outcomes of patients with HCC (collection of data of disease status during the course of the study and the outcome of treatment)
    date_rangeTime Frame:
    up to 3,3 years
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of treatment modalities that are used for patients with HCC during the course of their disease (collection of data of all treatments prescribed during the course of the study)
    date_rangeTime Frame:
    up to 3,3 years
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events)
    date_rangeTime Frame:
    up to 3,3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Evaluation efficacy parameters including: overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR) and stable disease (SD) rate of the various interventions employed in the care of patients with HCC
    date_rangeTime Frame:
    up to 3,3 years
    enhanced_encryption
    Safety Issue:
    No
  • To evaluate the comorbidities in patients with HCC and their influence on treatment options and outcome (collection of data on concomitant diseases)
    date_rangeTime Frame:
    up to 3,3 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Non interventional study in patients with diagnosis of HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment
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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.