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

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tularik

Criteria

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