The study's primary objective is to evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

Condition	Treatment or Intervention	Phase
Carcinoma, Hepatocellular	Drug: Bay 43-9006	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• biopsy-proven primary Hepatocellular Carcinoma
• life expectancy of at least 12 weeks
• inoperable tumor
• patient considered appropriate for systemic therapy
• at least one measurable lesion
• have not received chemotherapy or immunotherapy
• adequate bone morrow, liver and renal functions as determined by laboratory tests
• cirrhotic status of Child's Pugh class A or B
• Written Informed Consent form signed prior to start

Exclusion Criteria:

• congestive heart failure
• serious cardiac arrhythmia
• active coronary artery disease ischemia
• active clinically serious infections
• known history of HIV infection
• known metastatic brain or meningeal tumors
• history of seizure disorder
• history of organ allograft
• previous malignancy or other malignancies previously treated more than 3 years prior to entry
• patients with clinically significant GI bleeding within one month of study entry

California
      Metropolitan Hematology/Oncology Group, Los Angeles,  California,  90057,  United States
New York
      Mem. Sloan Kettering Cancer Center, New York,  New York,  10022,  United States

Study chairs or principal investigators

Amy Spitzer,  Study Coordinator, Kenmar Research, 201 S. Alvardo St., Suite 809, Los Angeles, CA 90057   

Study ID Numbers:  Protocol No. 10874; Raf Kinase Inhibitor; Bay 54-9085; (Bay 43-9006 tosylate salt)
Record last reviewed:  November 2004
Record first received:  August 30, 2002
ClinicalTrials.gov Identifier:  NCT00044512
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10