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

Tularik

Status and phase

Suspended

Phase 2

Conditions

Gastric Cancer

Esophageal Neoplasms

Treatments

Drug: T900607-sodium intravenous

Study type

Interventional

Funder types

Industry

Identifiers

NCT00048529

T-607-006

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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