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
Phase of Trial: Phase I/II
Latest Information Update: 10 Dec 2018
At a glance
- Drugs GEN 1 (Primary) ; Carboplatin; Paclitaxel
- Indications Adenocarcinoma; Carcinoma; Endometrial cancer; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
- Focus Therapeutic Use
- Acronyms OVATION 2; OVATION II
- Sponsors Celsion Corporation
- 22 Oct 2018 According to a Celsion Corporation media release, Celsion has begun dosing patients in the dose escalation portion of this study.The first 12 patients will be treated in the Phase I dose escalation portion followed by 118 patients in Phase II. The Study will be conducted in up to 15 medical centers. Data from the dose-escalating portion of OVATION 2 are expected in the first half of 2019.
- 06 Sep 2018 According to a Celsion Corporation media release, first patient has been randomized and dosed in this newly diagnosed Stage III/IV ovarian cancer study.
- 31 Aug 2018 Biomarkers information updated