NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2033210278

Registered date:27/08/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedEpithelial ovarian cancer (including primary peritoneal and fallopian tube cancers)
Date of first enrollment09/06/2021
Target sample size30
Countries of recruitmentUnited states,Israel,Poland,Spain,Japan
Study typeInterventional
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 maximumNot applicable
GenderFemale
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

Contact

Public contact
Name Makoto Baba
Address 1-4-10 Kyobashi, Chuo-ku, Tokyo Tokyo Japan 104-0031
Telephone +81-3-3241-0551
E-mail baba@nanocarrier.co.jp
Affiliation NanoCarrier Co., Ltd.
Scientific contact
Name Keiichi Fujiwara
Address 1397-1 Yamane, Hidaka-City, Saitama Saitama Japan 350-1298
Telephone +81-42-984-4637
E-mail fujiwara@saitama-med.ac.jp
Affiliation Saitama Medical University International Medical Center