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

Point Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Neoplasm Metastasis

Adenocarcinoma

Pancreatic Cancer

Treatments

Drug: talabostat mesylate tablets

Drug: gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00116389

PTH-320

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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