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

Primary Purpose

Recurrent Platinum Resistant Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VB-111 + Paclitaxel
Placebo + Paclitaxel
Sponsored by
Vascular Biogenics Ltd. operating as VBL Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Platinum Resistant Ovarian Cancer focused on measuring Recurrent Ovarian cancer, Platinum resistant ovarian cancer, Ovarian cancer, Ovarian carcinoma, Epithelial ovarian cancer, paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female patients ≥18 years of age
  2. Histologically confirmed epithelial ovarian cancer and documented disease.
  3. Patients must have platinum-resistant disease
  4. Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
  5. ECOG PS 0-1.

  6. Adequate hematological functions:

    • ANC ≥ 1000/mm3
    • PLT ≥ 100,000/mm3
    • PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
  7. Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment).

Exclusion Criteria:

  1. Non-epithelial tumors (Carcino-sarcomas are excluded)
  2. Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
  3. History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma, adequately controlled, non-metastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
  4. Previous ovarian cancer treatment with >5 anticancer regimens.
  5. Any prior radiotherapy to the pelvis or whole abdomen.

  6. Inadequate liver function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft & Gault formula):

    • Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled)
    • Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).

  7. Inadequate renal function, defined as:

    • Serum creatinine > ULN OR
    • Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
  8. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  9. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
  10. History of stroke or transient ischemic attack within 6 months prior to day of randomization.
  11. Patient with proliferative and/or vascular retinopathy
  12. Known brain metastases
  13. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
  14. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  15. History of abdominal fistula or gastrointestinal perforation.
  16. Current signs and symptoms of bowel obstruction
  17. Uncontrolled active infection
  18. Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy

Sites / Locations

  • UAB Division of GYN Oncology
  • Western Regional Medical Center
  • Arizona Oncology Associates, PC - HAL - USO
  • Arizona Oncology Associates, PC - HAL - USO
  • University of Arizona Cancer Center
  • UCLA-JCCC-Women's Health Clinical Research Unit
  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
  • University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center
  • University of California - San Francisco
  • Sansum Clinic - USO
  • Olive View UCLA Medical Center
  • Hartford HealthCare Cancer Institute at the Hospital of Central Ct
  • Hartford Healthcare
  • UF Health
  • University of Miami
  • Emory University
  • Rush University Medical Center
  • Carle Cancer Center
  • Midwestern Regional Medical Center, Inc
  • Parkview Cancer Institute
  • Indiana University School of Medicine
  • St. Vincent Gynecologic Oncology
  • University of Kansas Cancer Center
  • University of Kentucky
  • Ochsner Clinic Foundation
  • University of Maryland
  • Holy Cross Hospital
  • Massachusetts General Hospital
  • University of Michigan
  • Karmanos Cancer Institute
  • Henry Ford Health Hospital
  • Dartmouth- Hitchcock Medical Center
  • Atlantic Health System/Morristown Medical Center
  • Rutgers New Jersey Medical School
  • New Mexico Cancer Care Alliance
  • Women's Cancer Care Associates, LLC
  • Westchester Medical Center
  • Northwell Health Cancer Institute
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center
  • SUNY Upstate Medical University
  • UNC Chapel Hill
  • Duke University-Duke Cancer Institute
  • Wake Forest Baptist Medical Center
  • Sanford Medical Center
  • University of Cincinnati
  • Womens Cancer Center/Kettering Cancer Care
  • University of Oklahoma Health Sciences Center-Stephenson Cancer Center
  • Willamette Valley Cancer Institute and Research Center
  • St. Luke's University Health Network
  • Penn State Hershey Medical Center
  • The University of Pennsylvania
  • Fox Chase Cancer Center
  • West Penn Hospital
  • GHS Cancer Institute
  • Sanford Clinical Research
  • Texas Oncology, Austin Central - USO
  • Memorial Hermann
  • UT Health
  • Universtiy of Vermont
  • MultiCare Institute for Research & Innovation
  • University of Wisconsin
  • Marshfield Clinic Cancer Care & Research Center
  • Froedtert and Medical College of Wisconsin
  • Rambam Medical Center
  • Hadassah Medical Center
  • Shaare Tzedek Medical Center
  • Rabin Medical Center
  • Chaim Sheba Medical Center
  • Kaplan Medical Center, Department of Oncology
  • Aichi Cancer Center
  • National Cancer Center Hospital East
  • Ehime University Hospital
  • Kurume University Hospital
  • Sapporo Medical University Hospital
  • Iwate Medical University Hospital
  • Tohoku University Hospital
  • National Defense Medical College Hospital
  • National Cancer Center Hospital
  • Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Niigata Cancer Center Hospital
  • Hokkaido University Hospital
  • Centrum Badan Klinicznych Jagiellonskiego Centrum Innowacji
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • MedPolonia Sp. z o.o.
  • Parc Taulí Hospital Universitari Edifici Santa Fe, Planta 0, Sala de recerca 3
  • Institut Català d'Oncologia - Hospital Duran i Reynals
  • Hospital Universitario de Donostia Edificio Onkologikoa- Planta baja, Sala de Ensayos Clinicos
  • Hospital Gregorio Marañon Módulo prefabricado Oncología, Planta Baja
  • MD Anderson Cancer Center Madrid Unidad de ensayos Clinicos
  • Hospital Universitario Clínico San Carlos.
  • Hospital Universitario Virgen del Rocío Servicio Oncología Médica. Ensayos Clínicos. Edificio CDCA
  • Instituto Valenciano de Oncología Médica (IVO
  • Consorcio Hospitalario General Universitario de Valencia Servicio de Oncología Médica - Unidad de Investigación

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

VB-111 + Paclitaxel

Placebo + Paclitaxel

Outcomes

Primary Outcome Measures

Overall Survival
Progression Free Survival (PFS) by RECIST 1.1

Secondary Outcome Measures

Combined CA-125 and RECIST 1.1 response (GCIG)
CA-125 Response (GCIG)
Objective response rate (ORR) by RECIST 1.1
OS100 for a sensitivity analysis of OS

Full Information

First Posted
January 7, 2018
Last Updated
January 8, 2023
Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
Collaborators
GOG Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03398655
Brief Title
A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)
Acronym
OVAL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
July 19, 2022 (Actual)
Study Completion Date
July 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
Collaborators
GOG Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Platinum Resistant Ovarian Cancer
Keywords
Recurrent Ovarian cancer, Platinum resistant ovarian cancer, Ovarian cancer, Ovarian carcinoma, Epithelial ovarian cancer, paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
VB-111 + Paclitaxel
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Placebo + Paclitaxel
Intervention Type
Drug
Intervention Name(s)
VB-111 + Paclitaxel
Other Intervention Name(s)
Ofranergene Obadenovec
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo + Paclitaxel
Intervention Description
Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
From randomization until death from any cause (up to 5 years after last study treatment)
Title
Progression Free Survival (PFS) by RECIST 1.1
Time Frame
From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (up to 5 years after last study treatment)
Secondary Outcome Measure Information:
Title
Combined CA-125 and RECIST 1.1 response (GCIG)
Time Frame
From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
Title
CA-125 Response (GCIG)
Time Frame
From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
Title
Objective response rate (ORR) by RECIST 1.1
Time Frame
From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
Title
OS100 for a sensitivity analysis of OS
Time Frame
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients ≥18 years of age Histologically confirmed epithelial ovarian cancer and documented disease. Patients must have platinum-resistant disease Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment. ECOG PS 0-1. Adequate hematological functions: ANC ≥ 1000/mm3 PLT ≥ 100,000/mm3 PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT. Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment). Exclusion Criteria: Non-epithelial tumors (Carcino-sarcomas are excluded) Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors. History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma, adequately controlled, non-metastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast. Previous ovarian cancer treatment with >5 anticancer regimens. Any prior radiotherapy to the pelvis or whole abdomen. Inadequate liver function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft & Gault formula): Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled) Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases). Inadequate renal function, defined as: Serum creatinine > ULN OR Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula) New York Heart Association (NYHA) Grade II or greater congestive heart failure History of myocardial infarction or unstable angina within 6 months prior to day of randomization. History of stroke or transient ischemic attack within 6 months prior to day of randomization. Patient with proliferative and/or vascular retinopathy Known brain metastases History of hemoptysis or active GI bleeding within 6 month prior to day of randomization Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). History of abdominal fistula or gastrointestinal perforation. Current signs and symptoms of bowel obstruction Uncontrolled active infection Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy
Facility Information:
Facility Name
UAB Division of GYN Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35344
Country
United States
Facility Name
Western Regional Medical Center
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL - USO
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL - USO
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
UCLA-JCCC-Women's Health Clinical Research Unit
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Sansum Clinic - USO
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Olive View UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Hartford HealthCare Cancer Institute at the Hospital of Central Ct
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06053
Country
United States
Facility Name
Hartford Healthcare
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Midwestern Regional Medical Center, Inc
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Parkview Cancer Institute
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
St. Vincent Gynecologic Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
20114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
04801
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dartmouth- Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Atlantic Health System/Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07928
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
New Mexico Cancer Care Alliance
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Women's Cancer Care Associates, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Westchester Medical Center
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Northwell Health Cancer Institute
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
Duke University-Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Womens Cancer Center/Kettering Cancer Care
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
University of Oklahoma Health Sciences Center-Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
St. Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
GHS Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sanford Clinical Research
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Texas Oncology, Austin Central - USO
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UT Health
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Universtiy of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Marshfield Clinic Cancer Care & Research Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Froedtert and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Shaare Tzedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Kaplan Medical Center, Department of Oncology
City
Rehovot
Country
Israel
Facility Name
Aichi Cancer Center
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Ehime University Hospital
City
Tōon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Myagi
Country
Japan
Facility Name
National Defense Medical College Hospital
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Centrum Badan Klinicznych Jagiellonskiego Centrum Innowacji
City
Kraków
ZIP/Postal Code
30-348
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
MedPolonia Sp. z o.o.
City
Poznań
ZIP/Postal Code
60-375
Country
Poland
Facility Name
Parc Taulí Hospital Universitari Edifici Santa Fe, Planta 0, Sala de recerca 3
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Institut Català d'Oncologia - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario de Donostia Edificio Onkologikoa- Planta baja, Sala de Ensayos Clinicos
City
Donostia
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Gregorio Marañon Módulo prefabricado Oncología, Planta Baja
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
MD Anderson Cancer Center Madrid Unidad de ensayos Clinicos
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos.
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío Servicio Oncología Médica. Ensayos Clínicos. Edificio CDCA
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valenciano de Oncología Médica (IVO
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Consorcio Hospitalario General Universitario de Valencia Servicio de Oncología Médica - Unidad de Investigación
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33637348
Citation
Arend RC, Monk BJ, Herzog TJ, Moore KN, Shapira-Frommer R, Ledermann JA, Tewari KS, Secord AA, Rachmilewitz Minei T, Freedman LS, Miller A, Shmueli SF, Lavi M, Penson RT. 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. Gynecol Oncol. 2021 May;161(2):496-501. doi: 10.1016/j.ygyno.2021.02.014. Epub 2021 Feb 23.
Results Reference
derived
Links:
URL
http://www.vblrx.com/
Description
VBL Therapeutics Company Website

Learn more about this trial

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

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