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

Phase 2

Terminated

• Conditions: Pancreatic Cancer; Neoplasm Metastasis; Adenocarcinoma

• Registration Number: NCT00116389
• Lead Sponsor: Point Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-06-28
• Study First Submitted QC: 2005-06-28
• Study First Posted: 2005-06-29
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-07
• Last Update Posted: 2007-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
6 month survival

Secondary Outcome Measures

Name	Time	Method
overall survival
progression-free survival (PFS)
quality of life
pain
performance status

Trial Locations

Locations (27)

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; 🇺🇸 Mt. 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

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