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

Trial Status: Active

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.

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

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Grace M Facio
Phone: 323-409-7027ext3511
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: APPROVED
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Emory University Hospital Midtown
Status: ACTIVE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Rachel Lynn Alvey
Phone: 317-278-6455

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Adam Hisham Al Douri
Phone: 913-945-7547

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Janie Wangdali
Phone: 410-328-7496

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE

New Jersey

Newark
Rutgers New Jersey Medical School
Status: ACTIVE

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: APPROVED

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Vascular Biogenics

  • Primary ID VB-111-701/GOG-3018
  • Secondary IDs NCI-2018-01995
  • Clinicaltrials.gov ID NCT03398655