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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
WinSanTor, Inc·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Chemotherapy-induced Peripheral Neuropathy
Drug/Device/Intervention
WST-057 Active
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
WinSanTor, Inc
Location
Goshen,Ogden, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Aug 15, 2022
End date
May 30, 2024
Enrollment
60 participants
Primary outcome

Incidence of Treatment-Emergent Adverse Events as assessed by hematology and chemistry blood tests.,Incidence of Treatment-Emergent Adverse Events as assessed by vital signs (blood pressure (diastolic and systolicmmHg), heart rate (beats per minute), respiratory rate (breaths per minute).,Incidence of Treatment-Emergent Adverse Events as assessed by ECG (measuring P Wave, QRS complex, QT interval),Incidence of Treatment-Emergent Adverse Events as assessed by a dermal assessment (Draize score (scale 0.0-4.0) of the dosing area,Incidence of Treatment-Emergent Adverse Events as assessed by physical examination,Incidence of Treatment-Emergent Adverse Events as assessed by tumor evaluation using RECIST v1.1

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).

ICD-10 classifications
Drug-induced polyneuropathyParaneoplastic neuromyopathy and neuropathyPolyneuropathy due to other toxic agentsIdiopathic peripheral autonomic neuropathyIdiopathic progressive neuropathy
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05488873
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05488873 through Pure Global AI's free database. This Phase 2 trial is sponsored by WinSanTor, Inc and is currently Not yet recruiting. The study focuses on Chemotherapy-induced Peripheral Neuropathy. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.