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

NCT03398655 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2023-01-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • GOG Foundation

    collaborator NETWORK

  • Vascular Biogenics Ltd. operating as VBL Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2022-07-19
Completion
2022-07-19
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Japan
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03398655 on ClinicalTrials.gov