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 on June 28, 2005. Last Updated on 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 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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Pancrelipase Gemcitabine Gemcitabine hydrochloride

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

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

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
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012