Aravive, Inc. announced the achievement of full enrollment in the registrational Phase 3 trial of batiraxcept plus paclitaxel for platinum-resistant ovarian cancer (PROC). The global, randomized, double-blind, placebo-controlled Phase 3 AXLerate-OC trial is evaluating efficacy and tolerability of 15 mg/kg batiraxcept in combination with weekly paclitaxel versus placebo in combination with weekly paclitaxel. The trial was planned to enroll approximately 350 patients with platinum resistant, high grade serous ovarian cancer who received 1-4 prior lines of therapy at approximately 165 sites in the U.S. and Europe.

About the Phase 3 PROC Trial: The global, randomized, double-blind, placebo-controlled adaptive trial (GOG-3059/ENGOT OV-66) is designed to evaluate efficacy and safety of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel. The trial is expected to enroll approximately 350 patients with high-grade serous ovarian cancer who have received one to four prior lines of therapy at approximately 165 sites in the U.S. and Europe. The primary endpoint for the trial is progression free survival and the secondary endpoint is overall survival. Exploratory endpoints include objective response rate, duration of response, quality of life, clinical benefit rate, pharmacokinetic and pharmacodynamic profile, and sAXL/GAS6 ratio.

This trial is being conducted in partnership with The GOG Foundation, Inc. (GOG-F), through the GOG Partners program in the USA and in partnership with the European Network for Gynaecological Oncological Trial (ENGOT) groups in Europe.