Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.
NCT ID: NCT00043459
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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TERMINATED
PHASE2
35 participants
INTERVENTIONAL
2002-07-31
2003-03-31
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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intravenous T900607-sodium
Eligibility Criteria
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Inclusion Criteria
* Subjects must have received prior chemotherapy for their NHL
* 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,
* Hemoglobin at least 8.5 g/dL,
* Creatinine within 2 times upper limit of normal,
* AST and ALT within 3 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 NHL 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
Tularik
Locations
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Scripps Health Center
La Jolla, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Rush Medical Center
Chicago, Illinois, United States
Weill Medical College of Cornell University
New York, New York, United States
Countries
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Other Identifiers
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T-607-007
Identifier Type: -
Identifier Source: org_study_id