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

NCT05488873 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-22

No results posted yet for this study

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).

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DRUG

WST-057 Active

WST-057 Topical Solution

DRUG

Placebo

Matching Placebo Topical Solution

Sponsors & Collaborators

  • WinSanTor, Inc

    lead INDUSTRY

Principal Investigators

  • Angela Hansen · WinSanTor, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2026-04-26
Completion
2026-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05488873 on ClinicalTrials.gov