Status:
TERMINATED
Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
Lead Sponsor:
Point Therapeutics
Conditions:
Pancreatic Cancer
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00116389
Last Update
June 8 2007
Active Locations (28)
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1
Northwest Alabama Cancer Center, PC
Florence, Alabama, United States, 35630
2
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States, 35661
3
Oncology Associates, PC
Hartford, Connecticut, United States, 06106
4
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435