VB-111-70 (OVAL): A randomized, controlled, double-arm, double-blind, multi-center study of ofranergene obadenovec (VB-111) combined with paclitaxel versus paclitaxel combined with placebo for the treatment of recurrent platinum-resistant ovarian cancer

Including patients who:

• Are female and at least 18 years old
• Have histologically confirmed epithelial ovarian cancer and documented disease
• Have platinum-resistant disease
• Have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
• Have ECOG PS 0-1
• Have 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.
• Are known to carry a BRCA mutation, following PARP inhibitor treatment failure, intolerant of, or ineligible for PARP inhibitor treatment

Excluding patients who:

• Have non-epithelial tumors (Carcino-sarcomas are excluded)
• Have ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors
• Have a History of other clinically active malignancy within five 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
• Have previous ovarian cancer treatment with more than five anticancer regimens
• Have any prior radiotherapy to the pelvis or abdomen
• Have inadequate liver function, defined as:
  • 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).
• Have inadequate renal function, defined as:
  • Serum creatinine > ULN OR
  • Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
• Have New York Heart Association (NYHA) grade II or greater congestive heart failure
• Have a history of myocardial infarction or unstable angina within six months prior to day of randomization.
• Have a history of stroke or transient ischemic attack within 6 months prior to day of randomization
• Have proliferative and/or vascular retinopathy
• Have known brain metastases
• Have a history of hemoptysis or active GI bleeding within six months prior to day of randomization
• Have evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Have a history of abdominal fistula or gastrointestinal perforation
• Have current signs and symptoms of bowel obstruction
• Have uncontrolled active infection