An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer

An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma

The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival

Inclusion Criteria:

• Histologically confirmed diagnosis of hepatocellular carcinoma
• Patients must present with disease not amenable to curative surgery (i.e. either hepatectomy, or liver transplant).
• Evidence of measurable disease by radiographic technique
• Adequate organ function.

Exclusion Criteria:

• Prior treatment with any systemic treatment for liver cancer
• Presence of clinically relevant ascites
• Severe hemorrhage <4 weeks of starting study treatment.
• Diagnosis of second malignancy within last 3 years
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
• Known human immunodeficiency virus (HIV)
• Serious acute or chronic illness
• Current treatment on another clinical trial
• Pregnant or breastfeeding