NCT00327327

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: AmpliMed Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-02-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2006-05-18
• Last updated: 2010-09-15

Locations

9 sites across 1 country: United States