A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined With Paclitaxel vs. Paclitaxel Combined With Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer
A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined With Paclitaxel vs. Paclitaxel Combined With Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer
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:
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):
Inadequate renal function, defined as:
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
Orange, California 92868, United States
Orange, California 92868, United States
Hartford, Connecticut 06053, United States
Poughkeepsie, New York 12601, United States
Oklahoma City, Oklahoma 73104, United States
Shiwa-gun, Iwate 028-3695, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto, Tokyo 135-8550, Japan
Olsztyn, 10-228, Poland
Barcelona, 08208, Spain
Donostia / San Sebastian, 20014, Spain
Seville, 41013, Spain