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

This study has been terminated.
(FDA Hold May 2007)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00116389
First Posted: June 29, 2005
Last Update Posted: June 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Point Therapeutics
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Neoplasm Metastasis Adenocarcinoma Drug: talabostat mesylate tablets Drug: gemcitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Resource links provided by NLM:


Further study details as provided by Point Therapeutics:

Primary Outcome Measures:
  • 6 month survival

Secondary Outcome Measures:
  • overall survival
  • progression-free survival (PFS)
  • quality of life
  • pain
  • performance status

Estimated Enrollment: 60
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116389


  Show 28 Study Locations
Sponsors and Collaborators
Point Therapeutics
  More Information

ClinicalTrials.gov Identifier: NCT00116389     History of Changes
Other Study ID Numbers: PTH-320
First Submitted: June 28, 2005
First Posted: June 29, 2005
Last Update Posted: June 8, 2007
Last Verified: June 2007

Keywords provided by Point Therapeutics:
pancreatic cancer
cancer of the pancreas
adenocarcinoma of the pancreas
pancreatic neoplasms
Metastatic pancreatic cancer (Stage IV)
Stage IV Adenocarcinoma of the Pancreas

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Neoplasm Metastasis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Pancrelipase
Pancreatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents