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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00043433
Recruitment Status : Unknown
Verified April 2004 by Tularik.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Tularik

Tracking Information
First Submitted Date  ICMJE August 8, 2002
First Posted Date  ICMJE August 12, 2002
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Drug: intravenous T900607-sodium
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
35
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00043433
Other Study ID Numbers  ICMJE T-607-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Tularik
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Charlene Sum Tularik
PRS Account Tularik
Verification Date April 2004

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