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

This study has been terminated.
(FDA Hold May 2007)
Sponsor:
Information provided by:
Point Therapeutics
ClinicalTrials.gov Identifier:
NCT00116389
First received: June 28, 2005
Last updated: June 7, 2007
Last verified: June 2007
  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
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116389

  Show 28 Study Locations
Sponsors and Collaborators
Point Therapeutics
  More Information

No publications provided

ClinicalTrials.gov 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:
Adenocarcinoma
Neoplasms
Neoplasm Metastasis
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancreatin
Pancrelipase
Gemcitabine
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 23, 2014