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

Completed · Phase 3 · Has a placebo group

Conditions studied: Recurrent Platinum Resistant Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT03398655

Run by

Vascular Biogenics Ltd. operating as VBL Therapeutics

People needed

408

Starts

2017-12-19

Expected to finish

2022-07-19

Last updated by the study team

2023-01-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Western Regional Medical Center — Goodyear, Arizona, United States
• Arizona Oncology Associates, PC - HAL - USO — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - HAL - USO — Tempe, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• UCLA-JCCC-Women's Health Clinical Research Unit — Los Angeles, California, United States
• The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange — Orange, California, United States
• University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center — Orange, California, United States
• University of California - San Francisco — San Francisco, California, United States
• Sansum Clinic - USO — Santa Barbara, California, United States
• Olive View UCLA Medical Center — Sylmar, California, United States
• Hartford HealthCare Cancer Institute at the Hospital of Central Ct — Hartford, Connecticut, United States
• Hartford Healthcare — Hartford, Connecticut, United States
• UF Health — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Midwestern Regional Medical Center, Inc — Zion, Illinois, United States
• Parkview Cancer Institute — Fort Wayne, Indiana, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• St. Vincent Gynecologic Oncology — Indianapolis, Indiana, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• UAB Division of GYN Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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