A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Trial Profile

A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Jan 2018

At a glance

  • Drugs GEN 1 (Primary) ; Carboplatin; Paclitaxel
  • Indications Adenocarcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Therapeutic Use
  • Acronyms OVATION II
  • Sponsors Celsion Corporation
  • Most Recent Events

    • 04 Jan 2018 According to a Celsion Corporation media release, the U.S. FDA has accepted the Company's submission without comment, and has given clearance for this trial. The study will be conducted at upto 15 centers in the U.S. Company expects to have 25% of the study enrolled by the end of 2018.
    • 03 Jan 2018 Status changed from planning to not yet recruiting.
    • 20 Nov 2017 New trial record
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