drugset / Trial / NCT05488873

A Study of Topical Pirenzepine or Placebo in Oncology Patients With Chemotherapy Induced Peripheral Neuropathy

NCT05488873 ↗

Phase 2 Active not recruiting 60 enrolled WinSanTor, Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled adaptive study of the safety, tolerability, and exploratory efficacy of once-daily topical WST-057 administered for up to 19 weeks (or up to 24 weeks for subjects who experience a chemotherapy dose delay) to subjects who are also receiving 6 cycles (3 weeks apart) of Carboplatin AUC 5-6 and Paclitaxel 175 mg/m2 (with dose adjustment per institutional guidelines permitted).

Timeline

Start
2022-11-22
Primary completion
2026-04-26
Completion
2026-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pirenzepine Small molecule 4 ml Topical