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Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
This study is ongoing, but not recruiting participants.
Study NCT00043433   Information provided by Tularik
First Received: August 8, 2002   Last Updated: June 23, 2005   History of Changes

August 8, 2002
June 23, 2005
July 2002
 
 
 
Complete list of historical versions of study NCT00043433 on ClinicalTrials.gov Archive Site
 
 
 
Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
 

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

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Hepatocellular Carcinoma
Drug: intravenous T900607-sodium
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
35
 
 

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   China
 
NCT00043433
 
T-607-004
Tularik
 
Study Chair: Charlene Sum Tularik
Tularik
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP