Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00048529
• Other study ID #: T-607-006
• Status: Suspended
• Phase: Phase 2
• First received: November 1, 2002
• Last updated: June 23, 2005
• Start date: September 2002

Study information

• Verified date: April 2004
• Source: Tularik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a clinical research study of T900607-sodium to determine if it is effective and safe in treating gastric cancer and adenocarcinoma of the esophagus. Patients will be treated on a weekly basis with an intravenous injection of the study drug.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 70
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of gastric cancer or adenocarcinoma of the esophagus

• Subjects must have received 1-2 regimens of prior chemotherapy

• 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 2.5 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 gastric cancer or adenocarcinoma of the esophagus 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• T900607-sodium intravenous

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Pacific Oncology Associates	Los Gatos	California
United States	Scripps Health Center	San Diego	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tularik

Country where clinical trial is conducted

United States,