Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
NCT ID: NCT00116389
Last Updated: 2007-06-08
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
60 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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talabostat mesylate tablets
gemcitabine
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
* Measurable disease defined per RECIST
* Karnofsky Performance Status ≥50
* Expected survival ≥12 weeks
* Provide written informed consent
Exclusion Criteria
* Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
* Radiation therapy to \>25% of the bone marrow
* Clinically significant laboratory abnormalities
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* The need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy with \>10mg/day prednisone equivalents
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry.
* Pregnancy or lactation
18 Years
ALL
No
Sponsors
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Point Therapeutics
INDUSTRY
Locations
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Northwest Alabama Cancer Center, PC
Florence, Alabama, United States
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States
Oncology Associates, PC
Hartford, Connecticut, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States
Cancer Center of Florida
Ocoee, Florida, United States
Hematology Oncology Associates of Central Brevard
Rockledge, Florida, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States
Yagnesh V. Oza, MD
Mount Vernon, Illinois, United States
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States
Cancer Care Center, Inc.
New Albany, Indiana, United States
Medical Oncology LLC
Baton Rouge, Louisiana, United States
Huron Medical Center
Port Huron, Michigan, United States
Billings Clinic
Billings, Montana, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
New York Oncology Hematology/Albany Regional Cancer Center
Albany, New York, United States
Hematology-Oncology Associates of Rockland
New City, New York, United States
Dayton Oncology and Hematology
Kettering, Ohio, United States
Lawrence M. Stallings, MD
Wooster, Ohio, United States
Trilogy Cancer Center
Wooster, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Clinic, The
Portland, Oregon, United States
Cancer Center of the Carolinas
Greenville, South Carolina, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Texas Oncology, PA, Presbyterian
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Elkins Pancreas Center
Houston, Texas, United States
Saint Luke's Episcopal Hospital
Houston, Texas, United States
Cancer Care Northwest
Spokane, Washington, United States
Countries
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Other Identifiers
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PTH-320
Identifier Type: -
Identifier Source: org_study_id