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Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by:
AmpliMed Corporation
ClinicalTrials.gov Identifier:
NCT00327327
First received: May 17, 2006
Last updated: September 14, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Adenocarcinoma
 Drug: imexon
Drug: gemcitabine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by AmpliMed Corporation:

Primary Outcome Measures:
  • Determine maximally tolerated dose (MTD) [ Time Frame: until MTD reached ] [ Designated as safety issue: Yes ]
  • determine dose limiting toxicities. [ Time Frame: until MTD reached ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in plasma thiol levels [ Time Frame: until MTD reached ] [ Designated as safety issue: No ]
  • pharmacokinetics [ Time Frame: until MTD reached ] [ Designated as safety issue: No ]
  • objective tumor responses. [ Time Frame: until MTD reached ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: February 2004
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327327

Locations
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
Investigators
Principal Investigator: Mark Zalupski, MD University of Michigan
Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center
  More Information

Publications:

Responsible Party: Evan Hersh, VP Medical Affairs, AmpliMed Corporation
ClinicalTrials.gov Identifier: NCT00327327     History of Changes
Other Study ID Numbers: AMP-004
Study First Received: May 17, 2006
Last Updated: September 14, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on June 17, 2013