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

This study has been terminated.
(FDA Hold May 2007)
Information provided by:
Point Therapeutics Identifier:
First received: June 28, 2005
Last updated: June 7, 2007
Last verified: June 2007
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
Drug: talabostat mesylate tablets
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00116389

  Show 28 Study Locations
Sponsors and Collaborators
Point Therapeutics
  More Information

No publications provided Identifier: NCT00116389     History of Changes
Other Study ID Numbers: PTH-320 
Study First Received: June 28, 2005
Last Updated: June 7, 2007
Health Authority: United States: Food and Drug Administration

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:
Neoplasm Metastasis
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pancreatic Diseases
Pathologic Processes
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 08, 2016