Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Stopped early · Phase 2

Conditions studied: Pancreatic Cancer, Neoplasm Metastasis, Adenocarcinoma

In brief

The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.

Key facts

Study ID

NCT00116389

Run by

Point Therapeutics

People needed

60

Last updated by the study team

2007-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women age ≥18 years
• 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

You may not qualify if…

• CNS metastases
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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