A Study of Topical Pirenzepine or Placebo in Oncology Patients With Chemotherapy Induced Peripheral Neuropathy - Trial NCT05488873
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.
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Study Focus
Sponsor & Location
WinSanTor, Inc
Timeline & Enrollment
Phase 2
Aug 15, 2022
May 30, 2024
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
Data Source
ClinicalTrials.gov
NCT05488873
Non-Device Trial