Title: (OVAL) A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer
This study is to find out if a drug called VB-111 is a better treatment for ovarian cancer than the standard chemotherapy drug paclitaxel alone. VB-111 is investigational. This means that the US Food and Drug Administration (FDA) has not approved VB-111 for the treatment of ovarian cancer, and VB-111 can only be given in a research study. Paclitaxel is approved by the FDA for the treatment of ovarian cancer.
In this study, a computer will assign people by chance to get either the investigational drug, VB-111 in combination with the standard care drug paclitaxel, or the standard care drug, paclitaxel with placebo. You and your doctor will not be able to choose which drug you get. Study treatment will also be “blinded.” This means that, during the study, you and the researchers will not know if you are getting VB-111 or placebo. Blinded study treatment is a way to keep people’s expectations from influencing the study results.
Both drugs are given through an IV, which involves putting a needle into a vein in your arm. You will need to come to the hospital to get VB-111 or placebo every two months. You will need to come to the hospital to get paclitaxel weekly.
Over the course of the study, you will:
• fill out questionnaires about how you are feeling
• have blood drawn for research tests
• have biopsies for research
• have the same kinds of blood tests, physical exams and scans (x-rays, MRI, and CT scans) that you would have as part of standard cancer care to check your health
You will come to the hospital once a week for as long as you remain on study. The first visit of each 56-day cycle will take about 4-8 hours. Visits in weeks 2 – 8 will take about 2-4 hours.
You can be on study treatment until you have bad side effects, your disease gets worse, or you or the study doctor decide you should stop. Even after you stop study treatment, the research team would like to collect information from your medical records for up to 5 years.