Paclitaxel Lipid Suspension for Patients with Platinum-Resistant /Refractory Ovarian Cancer
Status:
NOT_YET_RECRUITING
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
This is a phase-3, open-label, multicenter, two-arm treatment study to evaluate the efficacy and safety of weekly Paclitaxel Lipid Suspension compared with weekly conventional paclitaxel in participants with platinum-resistant/refractory recurrent high-grade serous epithelial ovarian cancer.
Paclitaxel Lipid Suspension or conventional paclitaxel will be administered intravenously at a dose level of 80 mg/m2 on Day 1, Day 8 and Day 15 of each 28 days cycle.
The primary objective is to establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with conventional paclitaxel for Injection in participants with platinum-resistant/refractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and/or primary peritoneal cancer.
Participants in both arms will be dosed with the drug until disease progression as assessed by investigator and/or unacceptable toxicity.