T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients

This is an international, multicenter, randomized study of intravenous T138067 versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. A total of 750 subjects will be enrolled in this study.

Key inclusion criteria include:

• pathologic diagnosis of unresectable HCC
• chemotherapy-naïve for HCC
• Child-Pugh Class A or B liver disease
• measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI) or at least one lesion that is at least 10 mm on spiral CT scan
• Karnofsky Performance Status of ≥ 70%
• life expectancy of ≥ 12 weeks
• adequate hematologic function (i.e., absolute neutrophil count [ANC] of ≥ 1500 cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dL)
• total bilirubin of ≤ 1.5 upper limit of normal (ULN)
• aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ULN
• serum creatinine of ≤ 2 x ULN

Key exclusion criteria include:

• severe, concurrent disease that would make the subject inappropriate for enrollment
• Subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their HCC. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed)
• history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
• New York Heart Association (NYHA) class III or IV heart disease or a left ventricular ejection fraction of <50% or acute anginal symptoms
• females who are pregnant or breast-feeding
• received any investigational agent within 4 weeks of enrollment
• history of central nervous system metastases or carcinomatous meningitis
• clinically apparent ascites
• major surgery within 4 weeks of study enrollment