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

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborators: Amgen; Onyx Pharmaceuticals

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