Philadelphia, Pennsylvania 19111

  • Hepatocellular Carcinoma

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)


Study is Available At:


Original ID:

T-607-004


NCT ID:

NCT00043433


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Tularik


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:


Overall Contact Information

Official Name:Charlene Sum
Study Chair
Tularik

Study Dates

Start Date:July 2002
Verification Date:April 2004
Last Changed Date:June 23, 2005
First Received Date:August 8, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:intravenous T900607-sodium

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Tularik

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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