Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus
NCT ID: NCT00048529
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
70 participants
INTERVENTIONAL
2002-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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T900607-sodium intravenous
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tularik
INDUSTRY
Principal Investigators
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Kerrie Boyd
Role: STUDY_CHAIR
Locations
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Pacific Oncology Associates
Los Gatos, California, United States
Scripps Health Center
San Diego, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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T-607-006
Identifier Type: -
Identifier Source: org_study_id