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

This study has been terminated.

( FDA Hold May 2007 )

First Received: June 28, 2005 Last Updated: June 7, 2007 History of Changes

Sponsor:	Point Therapeutics
Information provided by:	Point Therapeutics
ClinicalTrials.gov Identifier:	NCT00116389

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Pancrelipase Gemcitabine Gemcitabine hydrochloride Talabostat Talabostat mesylate Ultrase

U.S. FDA Resources

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:

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

Study ID Numbers:	PTH-320
Study First Received:	June 28, 2005
Last Updated:	June 7, 2007
ClinicalTrials.gov Identifier:	NCT00116389 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Pancrelipase
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Gemcitabine

Endocrine Gland Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Gastrointestinal Agents
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on February 08, 2010