Trial | NCT00327327  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    105
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 Started
Feb 29
2004
Primary Completion
Oct 31
2009
Study Completion
Oct 31
2009
Last Update
Sep 15
2010
Estimate

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

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
No Results Posted