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

Open to females ages 18 years and up

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:
7. ANC ≥ 1000/mm3
8. PLT ≥ 100,000/mm3
9. PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
10. 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).

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):
7. Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled)
8. Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).
9. Inadequate renal function, defined as:
10. Serum creatinine > ULN OR
11. Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
12. New York Heart Association (NYHA) Grade II or greater congestive heart failure
13. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
14. . History of stroke or transient ischemic attack within 6 months prior to day of randomization.
15. . Patient with proliferative and/or vascular retinopathy
16. . Known brain metastases
17. . History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
18. . Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
19. . History of abdominal fistula or gastrointestinal perforation.
20. . Current signs and symptoms of bowel obstruction
21. . Uncontrolled active infection
22. . 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