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

NCT00116389 | Terminated Phase 2

• 1 other identifier: PTH-320
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 28

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.

Conditions

Pancreatic Cancer; Neoplasm Metastasis; Adenocarcinoma

Keywords

pancreatic cancer; cancer of the pancreas; adenocarcinoma of the pancreas; pancreatic neoplasms; Metastatic pancreatic cancer (Stage IV); Stage IV Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

• 6 month survival

Secondary Outcomes (5)

• overall survival

• progression-free survival (PFS)

• quality of life

• pain

• performance status

Interventions

talabostat mesylate tablets DRUG

gemcitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Point Therapeutics: lead

Study Sites (28)

Northwest Alabama Cancer Center, PC

Florence, Alabama, 35630, United States

Location

Northwest Alabama Cancer Center, PC

Muscle Shoals, Alabama, 35661, United States

Location

Oncology Associates, PC

Hartford, Connecticut, 06106, United States

Location

Palm Beach Institute of Hematology and Oncology

Boynton Beach, Florida, 33435, United States

Location

Cancer Center of Florida

Ocoee, Florida, 34761, United States

Location

Hematology Oncology Associates of Central Brevard

Rockledge, Florida, 32955, United States

Location

Gulfcoast Oncology Associates

St. Petersburg, Florida, 33705, United States

Location

Yagnesh V. Oza, MD

Mount Vernon, Illinois, 62864, United States

Location

Indiana Oncology Hematology Consultants

Indianapolis, Indiana, 46202, United States

Location

Cancer Care Center, Inc.

New Albany, Indiana, 47150, United States

Location

Medical Oncology LLC

Baton Rouge, Louisiana, 70809, United States

Location

Huron Medical Center

Port Huron, Michigan, 48060, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

New York Oncology Hematology/Albany Regional Cancer Center

Albany, New York, 12208, United States

Location

Hematology-Oncology Associates of Rockland

New City, New York, 10956, United States

Location

Dayton Oncology and Hematology

Kettering, Ohio, 45409, United States

Location

Lawrence M. Stallings, MD

Wooster, Ohio, 44691, United States

Location

Trilogy Cancer Center

Wooster, Ohio, 44691, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213-2933, United States

Location

Oregon Clinic, The

Portland, Oregon, 97213, United States

Location

Cancer Center of the Carolinas

Greenville, South Carolina, 29615, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

Texas Oncology, PA, Presbyterian

Dallas, Texas, 75231, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Elkins Pancreas Center

Houston, Texas, 77030, United States

Location

Saint Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Adenocarcinoma

Interventions

PT-100 dipeptide; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2005
• First Posted: June 29, 2005
• Last Updated: June 8, 2007

Record last verified: 2007-06

Locations

US (28)