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An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer, Neoplasm Metastasis, Adenocarcinoma

Thank you

Trial Information

An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6 month survival


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Neoplasm Metastasis
  • Adenocarcinoma
  • pancreatic cancer
  • cancer of the pancreas
  • adenocarcinoma of the pancreas
  • pancreatic neoplasms
  • Metastatic pancreatic cancer (Stage IV)
  • Stage IV Adenocarcinoma of the Pancreas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Neoplasm Metastasis
  • Pancreatic Neoplasms



Baylor College of Medicine Houston, Texas  77030
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Mary Crowley Medical Research Center Dallas, Texas  75246
Cancer Care Northwest Spokane, Washington  99202
Providence Portland Medical Center Portland, Oregon  97213-3635
Lawrence M. Stallings, MD Wooster, Ohio  44691
Hematology-Oncology Associates of Rockland Nyack, New York  10956
Cancer Center of the Carolinas Greenville, South Carolina  29615
Indiana Oncology Hematology Consultants Indianapolis, Indiana  46202
Cancer Center of Florida Ocoee, Florida  34761
Dayton Oncology and Hematology Kettering, Ohio  
Billings Clinic Billings, Montana  59107-7000
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
Elkins Pancreas Center Houston, Texas  77030
Palm Beach Institute of Hematology and Oncology Boynton Beach, Florida  33435
Huron Medical Center Port Huron, Michigan  48067
Northwest Alabama Cancer Center, PC Florence, Alabama  35630
Oncology Associates, PC Hartford, Connecticut  06106
Hematology Oncology Associates of Central Brevard Rockledge, Florida  32955
Yagnesh V. Oza, MD Mt. Vernon, Illinois  62864
Cancer Care Center, Inc. New Albany, Indiana  47150
Medical Oncology LLC Baton Rouge, Louisiana  70809
New York Oncology Hematology/Albany Regional Cancer Center Albany, New York  12208
Trilogy Cancer Center Wooster, Ohio  44691
Oregon Clinic, The Portland, Oregon  97213
Texas Oncology, PA, Presbyterian Dallas, Texas  75231
Saint Luke’s Episcopal Hospital Houston, Texas  77030