Pancreatic Cancer Clinical Trial
Official title:
An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
| NCT number | NCT00116389 |
| Other study ID # | PTH-320 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | June 28, 2005 |
| Last updated | June 7, 2007 |
| Verified date | June 2007 |
| Source | Point Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | New York Oncology Hematology/Albany Regional Cancer Center | Albany | New York |
| United States | Medical Oncology LLC | Baton Rouge | Louisiana |
| United States | Billings Clinic | Billings | Montana |
| United States | Palm Beach Institute of Hematology and Oncology | Boynton Beach | Florida |
| United States | Mary Crowley Medical Research Center | Dallas | Texas |
| United States | Texas Oncology, PA, Presbyterian | Dallas | Texas |
| United States | Northwest Alabama Cancer Center, PC | Florence | Alabama |
| United States | Cancer Center of the Carolinas | Greenville | South Carolina |
| United States | Oncology Associates, PC | Hartford | Connecticut |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Elkins Pancreas Center | Houston | Texas |
| United States | Saint Luke’s Episcopal Hospital | Houston | Texas |
| United States | Indiana Oncology Hematology Consultants | Indianapolis | Indiana |
| United States | Dayton Oncology and Hematology | Kettering | Ohio |
| United States | Monmouth Medical Center | Long Branch | New Jersey |
| United States | Yagnesh V. Oza, MD | Mt. Vernon | Illinois |
| United States | Northwest Alabama Cancer Center, PC | Muscle Shoals | Alabama |
| United States | Cancer Care Center, Inc. | New Albany | Indiana |
| United States | Hematology-Oncology Associates of Rockland | New City | New York |
| United States | Cancer Center of Florida | Ocoee | Florida |
| United States | Huron Medical Center | Port Huron | Michigan |
| United States | Oregon Clinic, The | Portland | Oregon |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Hematology Oncology Associates of Central Brevard | Rockledge | Florida |
| United States | Cancer Care Northwest | Spokane | Washington |
| United States | Gulfcoast Oncology Associates | St. Petersburg | Florida |
| United States | Lawrence M. Stallings, MD | Wooster | Ohio |
| United States | Trilogy Cancer Center | Wooster | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Point Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 6 month survival | |||
| Secondary | overall survival | |||
| Secondary | progression-free survival (PFS) | |||
| Secondary | quality of life | |||
| Secondary | pain | |||
| Secondary | performance status |
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