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
Description
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.
Status
Accepting new patients
Primary Study Objective(s)
The primary objective of this study is to determine overall survival.
Core eligibility
Note: This is only a partial list of eligibility criteria.
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
Principal Investigator(s)
Julian Schink
Natalie Godbee