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

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00043433
• Other study ID #: T-607-004
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 8, 2002
• Last updated: June 23, 2005
• Start date: July 2002

Study information

• Verified date: April 2004
• Source: Tularik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• intravenous T900607-sodium

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong
United States	University of New Mexico	Albuquerque	New Mexico
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center	Columbia	Missouri
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Scripps Health Center	La Jolla	California
United States	University of California San Diego	La Jolla	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Tularik

Countries where clinical trial is conducted

United States,  China,