SU011248 in Advanced Hepatocellular Carcinoma

• Participants will be given a supply of SU011248 capsules to be taken orally every morning for 4 weeks. After taking SU011248 for 4 weeks, there will be a 2 week rest period when the participant will not take any capsules. This 6-week period is referred to as 1 cycle.
• Participants will continue to receive SU011248 study treatment as long as their disease does not worsen significantly and they are not experiencing any serious side effects.
• During cycle 1 of study treatment, the participant will come to the outpatient clinic once a week for blood work, physical examination and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI), which is done two weeks after they start taking study treatment.
• During cycle two and every cycle thereafter, the participant will be asked to come to the outpatient clinic once every two weeks for physical examination, blood work and urine tests.
• A CT scan or MRI scan to assess the tumor will be performed once during each cycle for the first three cycles, then once every 2 cycles thereafter. ACTH stimulation test will be done every 2 cycles. A MUGA scan may be done at anytime at the discretion of the the study doctor.

Inclusion criteria

• Histologically or cytologically confirmed HCC and should have metastatic or locally advanced unresectable disease
• Measurable disease
• 0-1 prior systemic chemotherapy regimens for HCC
• Age 18 years or older
• Life expectancy of greater than 12 weeks
• ECOG performance status of 0-1
• Adequate organ and marrow function
• Women of child-bearing potential must have a negative pregnancy test prior to study entry

Exclusion criteria

• Chemotherapy, radiotherapy or major surgery within 4 weeks of study entry
• Receiving any other investigational agents within past 30 days
• Known brain metastases
• CLIP score > 3
• Chronic diarrhea or any disorder that will limit adequate absorption of SU011248
• Prolongation of QTc > 450 msec in screening electrocardiogram or history of familial long QT syndrome
• Uncontrolled intercurrent illness
• Pregnant or lactating women
• Greater than or equal to 2g of protein/24hr