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Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma

NCT01764009 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-09-11

No results posted yet for this study

Summary

The objective of the present trial is:

* to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma.
* to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP
* to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP

Conditions

Interventions

BIOLOGICAL

naked DNA coding for protein AMEP

injections 28days interval of 3 increasing doses of plasmid with electrotransfer

Sponsors & Collaborators

  • Valerio Therapeutics

    lead INDUSTRY

Principal Investigators

  • Bérangère VASSEUR, M.D. · BioAlliance Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • France
  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01764009 on ClinicalTrials.gov