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

Tularik

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: T138067 intravenous

Drug: doxorubicin intravenous

Study type

Interventional

Funder types

Industry

Identifiers

NCT00057382

T-067-010

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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