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Anti-microtubule agent

VB-111 + Paclitaxel for Ovarian Cancer (OVAL Trial)

Phase 3

Waitlist Available

Research Sponsored by Vascular Biogenics Ltd. operating as VBL Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment

Awards & highlights

OVAL Trial Summary

This trial tests whether VB-111, a new cancer drug, is better than placebo and paclitaxel (a standard ovarian cancer drug) at treating recurrent ovarian cancer.

Eligible Conditions

Ovarian Cancer

OVAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Progression Free Survival (PFS) by RECIST 1.1

Secondary outcome measures

CA-125 Response (GCIG)

Combined CA-125 and RECIST 1.1 response (GCIG)

OS100 for a sensitivity analysis of OS

+1 more

OVAL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1Experimental Treatment1 Intervention

VB-111 + Paclitaxel

Group II: Arm 2Active Control1 Intervention

Placebo + Paclitaxel

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VB-111 + Paclitaxel

2017

Completed Phase 3

~410

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK

42 Previous Clinical Trials

16,333 Total Patients Enrolled

8 Trials studying Ovarian Cancer

3,279 Patients Enrolled for Ovarian Cancer

Vascular Biogenics Ltd. operating as VBL TherapeuticsLead Sponsor

11 Previous Clinical Trials

1,273 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are VB-111 + Paclitaxel used to treat?

"VB-111 + Paclitaxel has been clinically shown to be effective against neoplasm metastasis, kaposi sarcoma, and advance directives."

Answered by AI

Are there opportunities for new enrollees in this clinical trial?

"You are correct, this study is not currently seeking patients. However, it's worth noting that the trial was first posted on December 19th, 2017 and last edited on March 21st, 2022. If you're interested in other studies, 1556 trials for relapse and 875 VB-111 + Paclitaxel trials are enrolling patients right now."

Answered by AI

What are the risks associated with VB-111 + Paclitaxel?

"VB-111 + Paclitaxel is estimated to be a 3 on Power's safety scale because it has reached Phase 3 clinical trials. This suggests that not only does this drug have some evidence supporting its efficacy, but also that there is extensive data demonstrating its safety."

Answered by AI

Is VB-111 + Paclitaxel a common combination in other medical research?

"The VB-111 + Paclitaxel combination was first studied in 1997. Since then, there have been a total of 1143 clinical trials completed with 875 still active as of now. Many of the ongoing studies are taking place in Winston-Salem, North carolina."

Answered by AI

Recent research and studies

Gynecologic OncologyJournal

Utilizing an Interim Futility Analysis of the OVAL Study (VB-111-701/GOG 3018) for Potential Reduction of Risk: A Phase III, Double Blind, Randomized Controlled Trial of Ofranergene Obadenovec (VB-111) and Weekly Paclitaxel in Patients with Platinum Resistant Ovarian Cancer

Arend, Rebecca C., Bradley J. Monk, Thomas J. Herzog, Kathleen N. Moore, Ronnie Shapira-Frommer, Jonathan A. Ledermann, Krishnansu S. Tewari, et al.. 2021. “Utilizing an Interim Futility Analysis of the OVAL Study (VB-111-701/GOG 3018) for Potential Reduction of Risk: A Phase III, Double Blind, Randomized Controlled Trial of Ofranergene Obadenovec (VB-111) and Weekly Paclitaxel in Patients with Platinum Resistant Ovarian Cancer”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2021.02.014.

clinicaltrials.govStudy

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

2017. "A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03398655.