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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
408
VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Overall Survival
Time frame: From randomization until death from any cause (up to 5 years after last study treatment)
Progression Free Survival (PFS) by RECIST 1.1
Time frame: From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (up to 5 years after last study treatment)
Combined CA-125 and RECIST 1.1 response (GCIG)
Time frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
CA-125 Response (GCIG)
Time frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
Objective response rate (ORR) by RECIST 1.1
Time frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
OS100 for a sensitivity analysis of OS
Time frame: From 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment
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UAB Division of GYN Oncology
Birmingham, Alabama, United States
Western Regional Medical Center
Goodyear, Arizona, United States
Arizona Oncology Associates, PC - HAL - USO
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HAL - USO
Tempe, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
UCLA-JCCC-Women's Health Clinical Research Unit
Los Angeles, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Orange, California, United States
University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California - San Francisco
San Francisco, California, United States
Sansum Clinic - USO
Santa Barbara, California, United States
...and 84 more locations