Safety Study Of Imexon Plus Gemcitabine In Untreated Pancreatic Adenocarcinoma

Study Overview

Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.

N/A

Pancreatic Adenocarcinoma

DRUG: imexon
DRUG: gemcitabine

AMP-004

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 2006-05-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-09-14
First Submitted that Met QC Criteria 2006-05-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-09-15
First Posted (ESTIMATED) 2006-05-18	Results First Posted N/A	Last Verified 2010-09

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
Determine maximally tolerated dose (MTD)		until MTD reached
determine dose limiting toxicities.		until MTD reached

Secondary Outcome Measures	Measure Description	Time Frame
Changes in plasma thiol levels		until MTD reached
pharmacokinetics		until MTD reached
objective tumor responses.		until MTD reached

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:

Inoperable cancer of the pancreas.
Blood cell counts and blood chemistries in or near normal range.
Able to perform the activities of daily living.
A projected life expectancy of at least 2 months.
If female, neither pregnant nor nursing.
Willing to use contraceptives to prevent pregnancy.
No other serious illnesses.
No other active malignancy.
No serious infections.
No current other drug therapy for the cancer or steroid therapy.
Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.

Prior chemotherapy for metastatic disease.
Brain metastases

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Mark Zalupski, MD, University of Michigan

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

Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007/s00280-009-1162-y. Epub 2009 Oct 24.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record