Study of IN10018 Plus Pegylated Liposomal Doxorubicin Compared to Placebo with Pegylated Liposomal Doxorubicin for Treating Platinum-Resistant Recurrent Ovarian Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of IN10018 combined with Pegylated Liposomal Doxorubicin PLD compared to placebo combined with PLD in women with platinum-resistant recurrent ovarian cancer, including fallopian tube and primary peritoneal cancers. This multicenter, randomized, double-blind Phase II study aims to improve treatment options for this condition by comparing these two approaches. Approximately 168 female participants will be randomly assigned in a 21 ratio to receive either IN10018 100 mg orally once daily with PLD 40 mgm2 intravenously every 4 weeks, or a placebo alongside PLD at the same dose and schedule. Participants are stratified based on prior bevacizumab use and the time since their last platinum-based therapy. The study follows strict protocols to monitor these treatments throughout the trial. Participants will undergo various assessments including tumor imaging to measure progression-free survival and other outcomes using RECIST 1.1 criteria, evaluated by independent reviewers and investigators over two years. Safety and tolerability will also be monitored. The study will last through treatment and follow-up phases, with overall survival tracked for up to three years. Regular health evaluations, laboratory tests, and performance status assessments will support participant monitoring throughout the trial.

IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer