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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Point Therapeutics
• Treatments: Gemcitabine; Pancreatin; Pancrelipase

Criteria

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