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

June 7, 2007 updated by: Point Therapeutics

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Florence, Alabama, United States, 35630
        • Northwest Alabama Cancer Center, Pc
      • Muscle Shoals, Alabama, United States, 35661
        • Northwest Alabama Cancer Center, Pc
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Oncology Associates, PC
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Palm Beach Institute of Hematology and Oncology
      • Ocoee, Florida, United States, 34761
        • Cancer Center of Florida
      • Rockledge, Florida, United States, 32955
        • Hematology Oncology Associates of Central Brevard
      • St. Petersburg, Florida, United States, 33705
        • Gulfcoast Oncology Associates
    • Illinois
      • Mt. Vernon, Illinois, United States, 62864
        • Yagnesh V. Oza, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Oncology Hematology Consultants
      • New Albany, Indiana, United States, 47150
        • Cancer Care Center, Inc.
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Medical Oncology LLC
    • Michigan
      • Port Huron, Michigan, United States, 48060
        • Huron Medical Center
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology/Albany Regional Cancer Center
      • New City, New York, United States, 10956
        • Hematology-Oncology Associates of Rockland
    • Ohio
      • Kettering, Ohio, United States, 45409
        • Dayton Oncology And Hematology
      • Wooster, Ohio, United States, 44691
        • Trilogy Cancer Center
      • Wooster, Ohio, United States, 44691
        • Lawrence M. Stallings, MD
    • Oregon
      • Portland, Oregon, United States, 97213-2933
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97213
        • Oregon Clinic, The
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Center Of The Carolinas
    • Texas
      • Dallas, Texas, United States, 75201
        • Mary Crowley Medical Research Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology, PA, Presbyterian
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Saint Luke's Episcopal Hospital
      • Houston, Texas, United States, 77030
        • Elkins Pancreas Center
    • Washington
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
6 month survival

Secondary Outcome Measures

Outcome Measure
quality of life
overall survival
pain
progression-free survival (PFS)
performance status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Point Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 28, 2005

First Submitted That Met QC Criteria

June 28, 2005

First Posted (ESTIMATE)

June 29, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2007

Last Update Submitted That Met QC Criteria

June 7, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTH-320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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