NCT05804370

Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)

A Phase 3 Multicenter Study of Gleolan™ (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Suspected Newly Diagnosed or Recurrent Epithelial Ovarian Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: NX Development Corp · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery. The study is planned to run for about 18 months with individual study participation lasting about two (2) weeks.

Detailed description

The study will be conducted in the following phases: * Part A1 is an open-label training phase of the study to optimize workflow and collect data on the tumor-to-background ratio (TBR) of images of Gleolan-induced fluorescence (FL). Participants will receive Gleolan followed by blue light (BL) assessment and bulk tumor biopsy with imaging to establish TBR. * Part A2 is an open-label training phase of the study to optimize workflow and obtain data to optimize the sample size estimate for Part B. Participants in Part A2 receive Gleolan and undergo Standard of Care (SoC) ovarian cancer debulking, followed by BL assessment and biopsy collection. * Part B is the randomized pivotal portion of the study for the evaluation of safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Gleolan	Gleolan is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The oral provision of Gleolan leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (wavelength \[λ\] = 375 - 450 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light.

Timeline

• Start date: 2024-05-30
• Primary completion: 2027-01-01
• Completion: 2027-05-01
• First posted: 2023-04-07
• Last updated: 2025-10-01

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study