Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

September 14, 2010 updated by: AmpliMed Corporation

A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center
    • Florida
      • Ocoee, Florida, United States, 34761
        • US Oncology Orlando, Cancer Centers of FL
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • US Oncology Indiana
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Univ Of Michigan
    • New York
      • Albany, New York, United States, 12208
        • US Oncology Albany, New York Oncology
    • Ohio
      • Kettering, Ohio, United States, 45409
        • US Oncology Kettering
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Ctr.
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • US Oncology, Virginia Oncology Assoc
    • Washington
      • Vancouver, Washington, United States, 98684
        • US Oncology Northwest, Northwest Cancer Specialists

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior chemotherapy for metastatic disease.
  • Brain metastases

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine maximally tolerated dose (MTD)
Time Frame: until MTD reached
until MTD reached
determine dose limiting toxicities.
Time Frame: until MTD reached
until MTD reached

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

AmpliMed Corporation

Investigators

  • Principal Investigator: Mark Zalupski, MD, University of Michigan

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (Estimate)

May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2010

Last Update Submitted That Met QC Criteria

September 14, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMP-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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