Paclitaxel Lipid Suspension for Patients with Platinum-Resistant /Refractory Ovarian Cancer

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.

NCT Number	NCT06867562
Lead Sponsor	Jina Pharmaceuticals Inc.
Conditions	Platinum-Resistant Primary Peritoneal Carcinoma, Platinum Resistant High Grade Epithelial Ovarian Cancer, Platinum Resistant High Grade Serous Ovarian Cancer
Enrollment	166 participants
Start Date	2025-04
Primary Completion	2025-12 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2025-03-10