NCT02518373

Effect of G17DT in Patients With Stage II/III Colorectal Cancer

An Open-label Volunteer Study of the Effect of G17DT on the Elevation of Plasma Gastrin Levels After Therapy With a Proton Pump Inhibitor (Omeperazole) in Patients With Treated Stage II/III Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cancer Advances Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study was an open label, single-center 18-week study to compare basal and meal stimulated plasma gastrin levels before and after treatment with 3 intramuscular injections of 250 µg G17DT, with and without the concomitant administration of Omeprazole.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	G17DT	G17DT is a therapeutic immunogen, formulated as a white, sterile, semi-viscous, water-in-oil emulsion (30:70 weight for weight). It was manufactured and supplied by Nova Laboratories Ltd., in glass ampoules containing 0.5 mL at a concentration of 1.25 mg/mL, as a single dose to be administered by intramuscular injection.
DRUG	Omeprazole	Proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease, laryngopharyngeal reflux, and Zollinger-Ellison syndrome.

Timeline

• Start date: 2000-04-01
• Primary completion: 2001-02-01
• Completion: 2001-02-01
• First posted: 2015-08-07
• Last updated: 2015-08-07