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Completed

NCT Number: NCT00327327

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.

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Key information

Conditions

Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Clinical Research Center, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

imexon

Drug

30-60 minutes IV, days 1,8,15 every 28 days

Gemcitabine

Drug

30 minutes IV, days 1,8,15 every 28 days

Primary outcomes

  1. Determine maximally tolerated dose (MTD)

    Time frame: until MTD reached

  2. determine dose limiting toxicities.

    Time frame: until MTD reached

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AmpliMed Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
May 18, 2006
Registry last updated
Sep 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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