Overview

AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy

Status:
Recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
Summary
This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method. Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).
Phase:
Phase 1
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator:
National Cancer Institute, France
Treatments:
Cisplatin