Epithelial ovarian cancer (including primary peritoneal and fallopian tube cancers)
Conditions
Interventions
Arm 1 (VB-111 combined with paclitaxel):
- VB-111 infused every 2 months (on day 1 of every cycle)
- Paclitaxel 80 mg/m2 as a 1-hour IV infusion weekly
Arm 2 (placebo combined with paclitaxel):
- Plac
Sponsors
Fujiwara Keiichi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Female patients at least 18 years old - Histologically confirmed epithelial ovarian cancer - Patients must have platinum-resistant disease - Patients must have disease that is measurable by RECIST 1.1 - ECOG PS 0-1
Exclusion criteria
Exclusion criteria: - Non-epithelial tumors - Ovarian tumors with low malignant potential, clear cell carcinomas, grade 1 serous tumors or mucinous tumors - History of other clinically active malignancy within 5 years of enrollment - Previous ovarian cancer treatment with >5 anticancer regimens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Overall survival - Progression free survival - Safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| - Combined CA-125 and RECIST 1.1 objective response rate - Objective response rate by RECIST 1.1 - CA-125 objective response rate - OS100 for a sensitivity analysis of OS | — |
Countries
Israel, Japan, Poland, Spain, United states
Contacts
Public ContactMakoto Baba
NanoCarrier Co., Ltd.
Outcome results
None listed