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GIDEON Non-Nexavar Arm - HCC Patients Who Are Treated With Any Therapy Other Than Nexavar at Individual Study Start

This study has been terminated.
(Study is officially cancelled bevore FPFV.)
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01191385
First received: August 27, 2010
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
  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.


Condition Intervention
Carcinoma, Hepatocellular
 Drug: Any treatment for unresectable HCC as chosen by the physician

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) [ Time Frame: up to 3,3 years ] [ Designated as 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) [ Time Frame: up to 3,3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: up to 3,3 years ] [ Designated as 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) [ Time Frame: up to 3,3 years ] [ Designated as safety issue: No ]
  • Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events) [ Time Frame: up to 3,3 years ] [ Designated as 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 [ Time Frame: up to 3,3 years ] [ Designated as 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) [ Time Frame: up to 3,3 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Any treatment for unresectable HCC as chosen by the physician
Only those patient are allowed to be enrolled that receive any HCC treatment for unresectable HCC as chosen by the physician except sorafenib. During the course of the study, each treatment is allowed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with unresectable HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment and who were never treated with sorafenib in the past

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191385

  Show 24 Study Locations
Sponsors and Collaborators
Bayer
Onyx Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT01191385     History of Changes
Other Study ID Numbers: 14611, NX0901
Study First Received: August 27, 2010
Last Updated: January 12, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Bayer:
HCC
Liver cancer
Cancer of liver
Cancer, liver
 Hepatic cancer
Cancer, hepatic
Carcinoma, hepatocellular

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 23, 2013