A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)
- Conditions
- Recurrent Platinum Resistant Ovarian Cancer
- Interventions
- Drug: VB-111 + PaclitaxelDrug: Placebo + Paclitaxel
- Registration Number
- NCT03398655
- Lead Sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 408
-
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).
-
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).
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 VB-111 + Paclitaxel VB-111 + Paclitaxel Arm 2 Placebo + Paclitaxel Placebo + Paclitaxel
- Primary Outcome Measures
Name Time Method Overall Survival From randomization until death from any cause (up to 5 years after last study treatment) Progression Free Survival (PFS) by RECIST 1.1 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 Measures
Name Time Method Combined CA-125 and RECIST 1.1 response (GCIG) From date of study entry until the date of death from any cause, or up to 5 years after last study treatment Objective response rate (ORR) by RECIST 1.1 From date of study entry until the date of death from any cause, or up to 5 years after last study treatment OS100 for a sensitivity analysis of OS 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 CA-125 Response (GCIG) From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
Trial Locations
- Locations (93)
Hartford HealthCare Cancer Institute at the Hospital of Central Ct
🇺🇸Hartford, Connecticut, United States
Women's Cancer Care Associates, LLC
🇺🇸Albany, New York, United States
Western Regional Medical Center
🇺🇸Goodyear, Arizona, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Instituto Valenciano de Oncología Médica (IVO
🇪🇸Valencia, Spain
MultiCare Institute for Research & Innovation
🇺🇸Tacoma, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Hospital Universitario Virgen del Rocío Servicio Oncología Médica. Ensayos Clínicos. Edificio CDCA
🇪🇸Sevilla, Spain
Iwate Medical University Hospital
🇯🇵Shiwa-gun, Iwate, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Hospital Universitario Clínico San Carlos.
🇪🇸Madrid, Spain
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Kaplan Medical Center, Department of Oncology
🇮🇱Rehovot, Israel
Shaare Tzedek Medical Center
🇮🇱Jerusalem, Israel
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Parc Taulí Hospital Universitari Edifici Santa Fe, Planta 0, Sala de recerca 3
🇪🇸Barcelona, Spain
Rambam Medical Center
🇮🇱Haifa, Israel
Marshfield Clinic Cancer Care & Research Center
🇺🇸Marshfield, Wisconsin, United States
Sanford Clinical Research
🇺🇸Sioux Falls, South Dakota, United States
Aichi Cancer Center
🇯🇵Nagoya, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Hospital Gregorio Marañon Módulo prefabricado Oncología, Planta Baja
🇪🇸Madrid, Spain
MD Anderson Cancer Center Madrid Unidad de ensayos Clinicos
🇪🇸Madrid, Spain
Ehime University Hospital
🇯🇵Tōon, Ehime, Japan
UCLA-JCCC-Women's Health Clinical Research Unit
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
🇵🇱Olsztyn, Poland
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Miami
🇺🇸Miami, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
St. Vincent Gynecologic Oncology
🇺🇸Indianapolis, Indiana, United States
Memorial Hermann
🇺🇸Houston, Texas, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
Duke University-Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
UT Health
🇺🇸San Antonio, Texas, United States
Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto, Tokyo, Japan
Tohoku University Hospital
🇯🇵Sendai, Myagi, Japan
National Defense Medical College Hospital
🇯🇵Tokorozawa, Saitama, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Japan
Hospital Universitario de Donostia Edificio Onkologikoa- Planta baja, Sala de Ensayos Clinicos
🇪🇸Donostia, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Consorcio Hospitalario General Universitario de Valencia Servicio de Oncología Médica - Unidad de Investigación
🇪🇸Valencia, Spain
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Health Hospital
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center-Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Froedtert and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
UAB Division of GYN Oncology
🇺🇸Birmingham, Alabama, United States
Arizona Oncology Associates, PC - HAL - USO
🇺🇸Tempe, Arizona, United States
University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Sansum Clinic - USO
🇺🇸Santa Barbara, California, United States
Hartford Healthcare
🇺🇸Hartford, Connecticut, United States
UF Health
🇺🇸Gainesville, Florida, United States
Olive View UCLA Medical Center
🇺🇸Sylmar, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Midwestern Regional Medical Center, Inc
🇺🇸Zion, Illinois, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Dartmouth- Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
New Mexico Cancer Care Alliance
🇺🇸Albuquerque, New Mexico, United States
Westchester Medical Center
🇺🇸Hawthorne, New York, United States
Northwell Health Cancer Institute
🇺🇸Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Womens Cancer Center/Kettering Cancer Care
🇺🇸Kettering, Ohio, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Texas Oncology, Austin Central - USO
🇺🇸Austin, Texas, United States
Universtiy of Vermont
🇺🇸Burlington, Vermont, United States
GHS Cancer Institute
🇺🇸Greenville, South Carolina, United States
Parkview Cancer Institute
🇺🇸Fort Wayne, Indiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
🇺🇸Orange, California, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Atlantic Health System/Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Sanford Medical Center
🇺🇸Fargo, North Dakota, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Centrum Badan Klinicznych Jagiellonskiego Centrum Innowacji
🇵🇱Kraków, Poland
MedPolonia Sp. z o.o.
🇵🇱Poznań, Poland