Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
This is a phase I trial to determine the maximum tolerated dose and recommended phase II
dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the
efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with
advanced ovarian cancer after debulking surgery.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer.
until either MTD is achieved or maximum planned dose is tested
Soon Beom Kang, MD, PhD
Seoul National University Hospital
Korea: Food and Drug Administration