Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Columbia, Missouri 65203


Purpose:

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


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)


NCT ID:

NCT00043433


Primary Contact:

Study Chair
Charlene Sum
Tularik


Backup Contact:

N/A


Location Contact:

Columbia, Missouri 65203
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.