drugset / Trial / NCT01764009
Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2012-06
- Primary completion
- 2013-12
- Completion
- 2014-03
Outcome
Outcome not reported
Stopped: “Study stopped due to low enrolment rate.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plasmid AMEP | Other / unclassified | 0.25 mg | Intramuscular |
| Subject | Plasmid AMEP | Other / unclassified | 1 mg | Intramuscular |
| Subject | Plasmid AMEP | Other / unclassified | 4 mg | Intramuscular |