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01
Overview
Phase 2, randomised, open-label trial of NanoPac in epithelial ovarian cancer (EOC) (5 arms), sponsored by NanOlogy. Primary endpoint: Treatment-emergent Adverse Events at 12 months. Started Apr 2017; status: terminated.
02
Design
5 arms- Study design
- RandomizedOpen-label
NanoPac 100 mg/m2
IP NanoPac 100 mg/m2 + SOC IV Chemo
NanoPac 200 mg/m2
IP NanoPac 200 mg/m2 + SOC IV Chemo
NanoPac 300 mg/m2
IP NanoPac 300 mg/m2 + SOC IV Chemo
NanoPac 400 mg/m2
IP NanoPac 400 mg/m2 + SOC IV Chemo
SOC
Standard of Care IV Chemo alone
03
Who it enrols
Women >= 18 years with epithelial ovarian cancer contained within the abdomen (or pleural effusion only) appropriate for cytoreductive surgery and IV platinum/paclitaxel. Recurrent disease must be platinum sensitive.
04
Endpoints
Primary
Treatment-emergent Adverse Events
Secondary
Maximum Plasma Concentration of Paclitaxel
Progression Free Survival
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