NCT01486329

VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer

VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer to Examine Safety, Tolerability, and Immune Response to the Investigational VEGFR-2 DNA Vaccine VXM01

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Vaximm GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First-in-human phase I dose escalation study in patients with locally advanced, inoperable and stage IV pancreatic cancer to examine safety, tolerability, and immune response to the investigational VEGFR-2 DNA vaccine VXM01 to examine safety and tolerability, clinical and immunogenic response to the investigational vascular endothelial growth factor receptor 2 (VEGFR-2) DNA vaccine VXM01, and to define the maximum tolerated dose.

Conditions

• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	VXM01	Live anti-angiogenic cancer vaccine drink solution, escalating dose
BIOLOGICAL	Placebo	Drink solution

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2011-12-06
• Last updated: 2015-06-08

Locations

1 site across 1 country: Germany