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NOT YET RECRUITING
NCT06867562
PHASE3

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

Sponsor: Jina Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2025-04

Completion Date

2026-03

Last Updated

2025-03-10

Healthy Volunteers

No

Interventions

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