NCT03398655

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

A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined With Paclitaxel vs. Paclitaxel Combined With Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

Conditions

• Recurrent Platinum Resistant Ovarian Cancer

Interventions

Type	Name	Description
DRUG	VB-111 + Paclitaxel	VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
DRUG	Placebo + Paclitaxel	Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week

Timeline

• Start date: 2017-12-19
• Primary completion: 2022-07-19
• Completion: 2022-07-19
• First posted: 2018-01-12
• Last updated: 2023-01-10

Locations

94 sites across 5 countries: United States, Israel, Japan, Poland, Spain

Regulatory

• FDA-regulated drug study