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

NCT01486329 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-06-08

No results posted yet for this study

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

BIOLOGICAL

VXM01

Live anti-angiogenic cancer vaccine drink solution, escalating dose

BIOLOGICAL

Placebo

Drink solution

Sponsors & Collaborators

  • Vaximm GmbH

    lead INDUSTRY

Principal Investigators

  • Thomas Schmidt, MD · University Clinics, Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486329 on ClinicalTrials.gov