A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Hepatocellular

In brief

The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

Key facts

Study ID

NCT00105443

Run by

Bayer

People needed

602

Starts

2005-03-01

Expected to finish

2008-11-01

Last updated by the study team

2014-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages eligible for study: 18 years and above, Genders eligible for study: both
• Patients who have a life expectancy of at least 12 weeks
• Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC)
• Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
• Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2

You may not qualify if…

• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] \& T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted
• Renal failure requiring hemo- or peritoneal dialysis
• History of cardiac disease
• Active clinically serious infections
• Known history of human immunodeficiency virus (HIV) infection
• Known central nervous system tumors including metastatic brain disease
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — San Francisco, California, United States
• Study site — Stanford, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.