NCT00043433

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Geographic Reach
2 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2002

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2004

First QC Date

August 8, 2002

Last Update Submit

June 23, 2005

Conditions

Hepatocellular Carcinoma

Keywords

HCC

Interventions

intravenous T900607-sodiumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Scripps Health Center

La Jolla, California, 92037, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Charlene Sum

    Tularik

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 8, 2002

First Posted

August 12, 2002

Study Start

July 1, 2002

Last Updated

June 24, 2005

Record last verified: 2004-04

Locations

CN(1)US(11)