Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

Phase 1 Completed 105 enrolled AmpliMed Corporation

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2004-02
Primary completion: 2009-10
Completion: 2009-10

Publications

Results Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007/s00280-009-1162-y. Epub 2009 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	imexon	Small molecule	200 mg/m2	Intravenous
Subject	imexon	Small molecule	280 mg/m2	Intravenous
Subject	imexon	Small molecule	1300 mg/m2	Intravenous

Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

Summary

Timeline

Publications

Drugs

Indications