NCT06551051

ADC-induced Neurotoxicity Treated With Duloxetine

A Single-arm Phase II Study of Duloxetine for the Treatment of Neurotoxicity Induced by Antibody-drug Conjugate

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is effective in treating peripheral neuropathy caused by antibody-drug conjugate. PURPOSE: This single arm phase II trial is studying duloxetine to see how well it works in treating peripheral neuropathy caused by antibody-drug conjugate in patients with cancer.

Detailed description

This study is a single arm phase II study. The study consisted of a screening period (subjects signed informed consent up to no more than 28 days before the first treatment of the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, intolerance of toxicities despite dose adjustments, or early withdrawal for any reason), and a follow up period (consisting of an end-of-treatment visit, a safety visit, and a survival follow up).

Conditions

• Solid Tumour

Interventions

Type	Name	Description
DRUG	duloxetine	Patients were treated with duloxetine at a recommended dose of 40mg/day, increasing to a maximum dose of 60mg/day after seven days of non-significant discomfort.

Timeline

• Start date: 2024-08-06
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-08-13
• Last updated: 2024-09-19

Locations

1 site across 1 country: China