NCT05488873

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

A Randomized, Double-Blind, Placebo-Controlled, Study of Topical Pirenzepine or Placebo for the Prevention of Dose Limiting Chemotherapy Induced Peripheral Neuropathy in Oncology Patients Administered Carboplatin and Paclitaxel

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: WinSanTor, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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). A Data Safety Monitoring Committee will review the safety data for all patients upon the completion of the first 10 patients. An interim analysis for safety and futility (primary and secondary endpoints) will be conducted after the first 20 subjects complete the trial. Based on this analysis an additional 20 subjects will be randomized and the power assessed. Depending on the statistical power after 40 subjects complete, a determination will be made as to whether or not to continue the recruitment up to a maximum of 60 subjects' completing the study.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	WST-057 Active	WST-057 Topical Solution
DRUG	Placebo	Matching Placebo Topical Solution

Timeline

• Start date: 2022-11-22
• Primary completion: 2026-04-26
• Completion: 2026-05-30
• First posted: 2022-08-05
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study