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
Who is this study for? Adult patients with recurrent platinum-resistant ovarian cancer
Status: Completed
Location: See all (94) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
Alabama
UAB Division of GYN Oncology
Birmingham
Arizona
Western Regional Medical Center
Goodyear
Arizona Oncology Associates, PC - HAL - USO
Phoenix
Arizona Oncology Associates, PC - HAL - USO
Tempe
University of Arizona Cancer Center
Tucson
California
UCLA-JCCC-Women's Health Clinical Research Unit
Los Angeles
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Orange
University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center
Orange
University of California - San Francisco
San Francisco
Sansum Clinic - USO
Santa Barbara
Olive View UCLA Medical Center
Sylmar
Connecticut
Hartford Healthcare
Hartford
Hartford HealthCare Cancer Institute at the Hospital of Central Ct
Hartford
Florida
UF Health
Gainesville
University of Miami
Miami
Georgia
Emory University
Atlanta
Illinois
Rush University Medical Center
Chicago
Carle Cancer Center
Urbana
Midwestern Regional Medical Center, Inc
Zion
Indiana
Parkview Cancer Institute
Fort Wayne
Indiana University School of Medicine
Indianapolis
St. Vincent Gynecologic Oncology
Indianapolis
Kansas
University of Kansas Cancer Center
Westwood
Kentucky
University of Kentucky
Lexington
Louisiana
Ochsner Clinic Foundation
New Orleans
Massachusetts
Massachusetts General Hospital
Boston
Maryland
University of Maryland
Baltimore
Holy Cross Hospital
Silver Spring
Michigan
University of Michigan
Ann Arbor
Henry Ford Health Hospital
Detroit
Karmanos Cancer Institute
Detroit
North Carolina
UNC Chapel Hill
Chapel Hill
Duke University-Duke Cancer Institute
Durham
Wake Forest Baptist Medical Center
Winston-salem
North Dakota
Sanford Medical Center
Fargo
New Hampshire
Dartmouth- Hitchcock Medical Center
Lebanon
New Jersey
Atlantic Health System/Morristown Medical Center
Morristown
Rutgers New Jersey Medical School
Newark
New Mexico
New Mexico Cancer Care Alliance
Albuquerque
New York
Women's Cancer Care Associates, LLC
Albany
Westchester Medical Center
Hawthorne
Northwell Health Cancer Institute
Lake Success
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center
Poughkeepsie
SUNY Upstate Medical University
Syracuse
Ohio
University of Cincinnati
Cincinnati
Womens Cancer Center/Kettering Cancer Care
Kettering
Oklahoma
University of Oklahoma Health Sciences Center-Stephenson Cancer Center
Oklahoma City
Oregon
Willamette Valley Cancer Institute and Research Center
Eugene
Pennsylvania
St. Luke's University Health Network
Bethlehem
Penn State Hershey Medical Center
Hershey
Fox Chase Cancer Center
Philadelphia
The University of Pennsylvania
Philadelphia
West Penn Hospital
Pittsburgh
South Carolina
GHS Cancer Institute
Greenville
South Dakota
Sanford Clinical Research
Sioux Falls
Texas
Texas Oncology, Austin Central - USO
Austin
Memorial Hermann
Houston
UT Health
San Antonio
Vermont
Universtiy of Vermont
Burlington
Washington
MultiCare Institute for Research & Innovation
Tacoma
Wisconsin
University of Wisconsin
Madison
Marshfield Clinic Cancer Care & Research Center
Marshfield
Froedtert and Medical College of Wisconsin
Milwaukee
Other Locations
Israel
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Shaare Tzedek Medical Center
Jerusalem
Rabin Medical Center
Petach Tikva
Chaim Sheba Medical Center
Ramat Gan
Kaplan Medical Center, Department of Oncology
Rehovot
Japan
National Cancer Center Hospital
Chuo-ku
National Cancer Center Hospital East
Kashiwa
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto
Kurume University Hospital
Kurume
Aichi Cancer Center
Nagoya
Niigata Cancer Center Hospital
Niigata
Hokkaido University Hospital
Sapporo
Sapporo Medical University Hospital
Sapporo
Tohoku University Hospital
Sendai
Iwate Medical University Hospital
Shiwa-gun
National Defense Medical College Hospital
Tokorozawa
Ehime University Hospital
Tōon
Poland
Centrum Badan Klinicznych Jagiellonskiego Centrum Innowacji
Kraków
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn
MedPolonia Sp. z o.o.
Poznań
Spain
Institut Català d'Oncologia - Hospital Duran i Reynals
Barcelona
Parc Taulí Hospital Universitari Edifici Santa Fe, Planta 0, Sala de recerca 3
Barcelona
Hospital Universitario de Donostia Edificio Onkologikoa- Planta baja, Sala de Ensayos Clinicos
Donostia
Hospital Gregorio Marañon Módulo prefabricado Oncología, Planta Baja
Madrid
Hospital Universitario Clínico San Carlos.
Madrid
MD Anderson Cancer Center Madrid Unidad de ensayos Clinicos
Madrid
Hospital Universitario Virgen del Rocío Servicio Oncología Médica. Ensayos Clínicos. Edificio CDCA
Sevilla
Consorcio Hospitalario General Universitario de Valencia Servicio de Oncología Médica - Unidad de Investigación
Valencia
Instituto Valenciano de Oncología Médica (IVO
Valencia
Time Frame
Start Date: 2017-12-19
Completion Date: 2022-07-19
Participants
Target number of participants: 408
Treatments
Experimental: Arm 1
VB-111 + Paclitaxel
Active_comparator: Arm 2
Placebo + Paclitaxel
Authors
Ignacio Romero Noguera, Rebecca Arend, Ama Buskwofie, Irina Dimitrova, John H Farley, Merry Markham, Marilyn Huang, Laura Holman, Bhavana Pothuri, Evelyn Cantillo, Samuel Lentz, Cheung Wong, Edwin Alvarez, Mark H Einstein, Thomas Krivak, Charles Anderson, Mary Cunningham, Christina Chu, Joyce Barlin, James Barter, Dana M Roque, Douglas Levine, Summer Dewdney, Katrina Wade, Jeanne Schilder, Tariq Mahmood, Thomas Woliver, Namita Khanna, Evelyn Fleming, Iwona Podzielinski, Paul Mayor, Christine Holschneider, Setsuko Chambers, Lisa Barroilhet, Thomas Buekers, Georgia McCann, Natalie Godbee, Nana Tchabo, Heidi Godoy, Marta Crispens, Jeffrey Elder, Nicholas Taylor, Thomas Herzog, Rabbie Hanna, Lisa Landrum, Richard Penson, Angeles Secord, Linda Van Le, Maria Grosse-Perdekamp, Joshua Cohen, Frederick Ueland, Joshua Kesterson, Michael G Teneriello, Krishnansu Tewari, Raúl Márquez, Julian Schink, Arlene Gayle, Bradley Monk, Andrea Jewell, Veena John, William Bradley, Ashley Haggerty, Jean-Marie Stephan, Maria Bell, Seth Fagbemi, Daliah Tsoref, Cristina Churruca, Lubomir Bodnar, Antonio Casado, Ronnie Shapira-Frommer, Yolanda García, Rodryg Ramlau, Amnon Amit, Ora Rosengarten, Purificación Estévez, Hidemichi Watari
Related Therapeutic Areas
Sponsors
Collaborators: GOG Foundation
Leads: Vascular Biogenics Ltd. operating as VBL Therapeutics