A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer

JRCT ID: jRCT2033210278

Registered date:27/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Epithelial ovarian cancer (including primary peritoneal and fallopian tube cancers)
• Date of first enrollment: 09/06/2021
• Target sample size: 30
• Countries of recruitment: United states,Japan,Israel,Japan,Poland,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

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):
- Placebo infused every 2 months (on day 1 of every cycle)
- Paclitaxel 80 mg/m2 as a 1-hour IV infusion weekly

Outcome(s)

Primary Outcome

- Overall survival
- Progression free survival
- Safety and tolerability

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fujiwara Keiichi
• Secondary ID(s): NCT03398655