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

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