- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00043459
Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.
June 23, 2005 updated by: Tularik
The purpose of the study is to determine whether T900607-sodium is effective and safe in treating non-Hodgkin's lymphoma.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92037
- Scripps Health Center
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Colorado
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Aurora, Colorado, United States, 80010
- University of Colorado Health Sciences Center
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Chicago, Illinois, United States, 60612
- Rush Medical Center
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New York
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New York, New York, United States, 10021
- Weill Medical College of Cornell University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL)
- 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
- 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kerrie Boyd, Tularik
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Study Completion
March 1, 2003
Study Registration Dates
First Submitted
August 8, 2002
First Submitted That Met QC Criteria
August 9, 2002
First Posted (Estimate)
August 12, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
March 1, 2003
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T-607-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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