Trial Of Talabostat And Gemcitabine In Patients With Stage IV Adenocarcinoma Of The Pancreas

Study Overview

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

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.

N/A

Pancreatic Cancer
Neoplasm Metastasis
Adenocarcinoma

DRUG: talabostat mesylate tablets
DRUG: gemcitabine

PTH-320

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-06-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2007-06-07
First Submitted that Met QC Criteria 2005-06-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2007-06-08
First Posted (ESTIMATED) 2005-06-29	Results First Posted N/A	Last Verified 2007-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
6 month survival

Secondary Outcome Measures	Measure Description	Time Frame
overall survival
progression-free survival (PFS)
quality of life
pain
performance status

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record