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

NCT ID: NCT01191385

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-12-31

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Any treatment for unresectable HCC as chosen by the physician

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Schering Pharma AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Multiple Locations, Arkansas, United States

Multiple Locations, California, United States

Multiple Locations, Colorado, United States

Multiple Locations, District of Columbia, United States

Multiple Locations, Florida, United States

Multiple Locations, Georgia, United States

Multiple Locations, Illinois, United States

Multiple Locations, Indiana, United States

Multiple Locations, Iowa, United States

Multiple Locations, Kentucky, United States

Multiple Locations, Louisiana, United States

Multiple Locations, Maryland, United States

Multiple Locations, Massachusetts, United States

Multiple Locations, Michigan, United States

Multiple Locations, Minnesota, United States

Multiple Locations, Missouri, United States

Multiple Locations, New Hampshire, United States

Multiple Locations, New Jersey, United States

Multiple Locations, New York, United States

Multiple Locations, Oregon, United States

Multiple Locations, Pennsylvania, United States

Multiple Locations, South Carolina, United States

Multiple Locations, Texas, United States

Multiple Locations, Virginia, United States

Countries

United States

Other Identifiers

NX0901

Identifier Type: -

Identifier Source: secondary_id

14611

Identifier Type: -

Identifier Source: org_study_id