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

NCT06867562 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-03-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jina Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2026-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867562 on ClinicalTrials.gov