Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.

Tularik

Status and phase

Unknown

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: intravenous T900607-sodium

Study type

Interventional

Funder types

Industry

Identifiers

T-607-004

Details and patient eligibility

About

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of HCC
Child-Pugh liver classification of A or B
Subjects must not have received prior chemotherapy or radiotherapy for their HCC
At least 18 years of age
Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
Karnofsky performance status of at least 70%
Estimated life expectancy of at least 12 weeks
Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
Subject must be able to comply with study procedures and follow-up examinations.
Signed written informed consent
Lab Values (obtained ≤ 7 days prior to study enrollment):
ANC at least 1.5x10e9/L,
Platelet count at least 100x10e9/L,
Creatinine within 2 times upper limit of normal
AST and ALT within 5 times upper limit of normal
Bilirubin within 1.5 times upper limit of normal
Albumin great than 2.8 g/dL

Exclusion Criteria

Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms
Patients who have received any investigational agent within 4 weeks of enrollment
Patients who are pregnant or breast-feeding
History of prior malignancy other than cancer studied within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
History of central nervous system metastases or carcinomatous meningitis
Major surgery within 4 weeks of enrollment
Patients who have received prior chemotherapy, chemoembolization, immunotherapy, or radiotherapy for their HCC. Prior surgical resection, intratumoral ethanol injection, hormonal therapy, cryosurgery, radiofrequency ablation, selective internal radiation or embolization, is permitted ONLY if > 6 weeks has passed since therapy and there is an indicator lesion (> 1 x 1 cm) outside the area of prior treatment (recurrence at the margin or resection is allowed)