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

Primary Purpose

Gastric Cancer, Esophageal Neoplasms

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
T900607-sodium intravenous
Sponsored by
Tularik
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring adenocarcinoma of the esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Oncology Associates
  • Scripps Health Center
  • Moffitt Cancer Center
  • University of New Mexico Cancer Research and Treatment Center
  • Ireland Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 2002
Last Updated
June 23, 2005
Sponsor
Tularik
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1. Study Identification

Unique Protocol Identification Number
NCT00048529
Brief Title
Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Suspended
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tularik

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Esophageal Neoplasms
Keywords
adenocarcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
T900607-sodium intravenous

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerrie Boyd
Official's Role
Study Chair
Facility Information:
Facility Name
Pacific Oncology Associates
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Scripps Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92137
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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