Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00327327
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : September 15, 2010
Information provided by:
AmpliMed Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: imexon Drug: gemcitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
Study Start Date : February 2004
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: imexon
    30-60 minutes IV, days 1,8,15 every 28 days
    Drug: gemcitabine
    30 minutes IV, days 1,8,15 every 28 days

Primary Outcome Measures :
  1. Determine maximally tolerated dose (MTD) [ Time Frame: until MTD reached ]
  2. determine dose limiting toxicities. [ Time Frame: until MTD reached ]

Secondary Outcome Measures :
  1. Changes in plasma thiol levels [ Time Frame: until MTD reached ]
  2. pharmacokinetics [ Time Frame: until MTD reached ]
  3. objective tumor responses. [ Time Frame: until MTD reached ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00327327

United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
United States, Florida
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, United States, 34761
United States, Indiana
US Oncology Indiana
Indianapolis, Indiana, United States, 46227
United States, Michigan
Univ of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
US Oncology Albany, New York Oncology
Albany, New York, United States, 12208
United States, Ohio
US Oncology Kettering
Kettering, Ohio, United States, 45409
United States, Pennsylvania
Fox Chase Cancer Ctr.
Philadelphia, Pennsylvania, United States, 19111
United States, Virginia
US Oncology, Virginia Oncology Assoc
Norfolk, Virginia, United States, 23502
United States, Washington
US Oncology Northwest, Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
AmpliMed Corporation
Principal Investigator: Mark Zalupski, MD University of Michigan
Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center

Publications of Results:
Responsible Party: Evan Hersh, VP Medical Affairs, AmpliMed Corporation Identifier: NCT00327327     History of Changes
Other Study ID Numbers: AMP-004
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs