NCT06867562

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

A Phase-3, Randomized, Parallel Group, Open-label, Multicenter, Two-Arm Treatment Study to Evaluate the Efficacy and Safety of Weekly Paclitaxel Lipid Suspension Compared with Weekly Conventional Paclitaxel in the Patients with Platinum-Resistant/Refractory Recurrent High-grade Serous Epithelial Ovarian Cancer Including Fallopian Tube And/or Primary Peritoneal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Jina Pharmaceuticals Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Platinum-Resistant Primary Peritoneal Carcinoma
• Platinum Resistant High Grade Epithelial Ovarian Cancer
• Platinum Resistant High Grade Serous Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel Lipid Suspension	The formulation consists of uniformly sized (\< 100 nm) particles of Paclitaxel suspended in a lipid-based formulation. The advantage of such a Lipid-Based formulation of Paclitaxel is an improvement of the safety profile by eliminating excipients, Cremophor and ethanol which are present in conventional Paclitaxel formulations (Taxol®).
DRUG	Conventional paclitaxel or Taxol	Conventional formulation with detergent Cremophor and alcohol

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-03-10
• Last updated: 2025-03-10

Regulatory

• FDA-regulated drug study