- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00048529
Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus
June 23, 2005 updated by: Tularik
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
70
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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Los Gatos, California, United States, 95032
- Pacific Oncology Associates
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San Diego, California, United States, 92137
- Scripps Health Center
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Florida
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico Cancer Research and Treatment Center
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Ohio
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Cleveland, Ohio, United States, 44106
- Ireland Cancer Center
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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 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
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
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
September 1, 2002
Study Registration Dates
First Submitted
November 1, 2002
First Submitted That Met QC Criteria
November 1, 2002
First Posted (Estimate)
November 4, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 2004
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T-607-006
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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University Hospitals Seidman Cancer CenterNational Cancer Institute (NCI)Completed
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Sheba Medical CenterTel Aviv UniversityCompletedVerifying the Correct Position of Intravenous CathetersIsrael
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The Western Pennsylvania HospitalWest Penn Allegheny Health SystemWithdrawnContrast Induced NephropathyUnited States
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Guy's and St Thomas' NHS Foundation TrustActive, not recruiting
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Imperial College LondonCompleted
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Hospital Universitario Ramon y CajalCompletedHeart Failure | Diabetes | Kidney Failure, Chronic | Kidney Failure, AcuteSpain