This Phase IIa exploratory 2-stage trial assessed the efficacy, safety and tolerability of CPC634 (CriPec® docetaxel) administered IV, Q3W to 25 subjects (13 in Stage 1 and 12 in Stage 2) with ovarian cancer that is resistant to prior platinum-based therapy. Subjects will be treated continuously every 21 days at 60 mg/m2, which is the RP2D of CPC634 (CriPec® docetaxel) that was determined in the Phase I CT-CL01, until disease progression, unacceptable toxicity, or discontinuation for any other reason.
The purpose of this study is to determine whether CPC634 (CriPec® docetaxel) is effective in the treatment of patients with advanced epithelial ovarian cancer who are resistant to prior platinum-based chemotherapy~.