WST-057 Active for Chemotherapy-induced Peripheral Neuropathy
Phase-Based Progress Estimates
Effectiveness
Safety
Community Cancer Trials of Utah (CCTU), Ogden, UT
Chemotherapy-induced Peripheral Neuropathy+1 More
WST-057 Active - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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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).
Eligible Conditions
- Chemotherapy-induced Peripheral Neuropathy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 18 Secondary · Reporting Duration: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Week 24
Activity and Fear of Falling Measurement (Short FES-I)
Chemotherapy dose modifications as assessed by median duration of delays (days) between chemotherapy treatments.
Chemotherapy dose modifications as assessed by percentage of patients requiring dose reductions of chemotherapy.
Chemotherapy dose modifications as assessed by the percentage of patients requiring dose delay of chemotherapy.
Chemotherapy dose modifications as assessed by the percentage of patients requiring replacement or change to initially prescribed chemotherapy (carboplatin/paclitaxel combination).
Chemotherapy dose modifications as assessed by the percentage of patients stopping chemotherapy before treatment is complete. chemotherapy (carboplatin/paclitaxel combination).
Dose limiting neuropathy as assessed by decrease in chemotherapy-induced peripheral sensory neuropathy ≥ Grade 3.
Dose limiting neuropathy as assessed by decrease in duration of sensory peripheral neuropathy ≥ Grade 3.
Dose limiting neuropathy as assessed by decrease in percentage of patients with sensory peripheral neuropathy ≥ Grade 3
Dose limiting neuropathy as assessed by increase in time to onset of sensory peripheral neuropathy ≥ Grade 3.
Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-13 (FACT/GOG-Ntx-13)
Hand Dexterity
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 hematology and chemistry blood tests.
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
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).
Intraepidermal Nerve Fiber Density
Neuropathy Total Symptom Score-6 (NTSS-6)
Patient-Reported Outcomes Measurement Information System (PROMIS)-physical function (short form)
Thermal Quantitative Sensory Testing (Cold)
Utah Early Neuropathy Score (UENS)
Visual Analogue Score (VAS)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
WST-057 Active
1 of 2
Placebo
1 of 2
Experimental Treatment
60 Total Participants · 2 Treatment Groups
Primary Treatment: WST-057 Active · Has Placebo Group · Phase 2
WST-057 Active
Drug
Experimental Group · 1 Intervention: WST-057 Active · Intervention Types: DrugPlacebo
Drug
Experimental Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Closest Location: Community Cancer Trials of Utah (CCTU) · Ogden, UT
N/AFirst Recorded Clinical Trial
1 TrialsResearching Chemotherapy-induced Peripheral Neuropathy
0 CompletedClinical Trials
Who is running the clinical trial?
WinSanTor, IncLead Sponsor
3 Previous Clinical Trials
176 Total Patients Enrolled
Marian Ijzerman, Ph.DStudy DirectorWinSanTor, Inc
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are able to understand the nature of a placebo-controlled trial and are able to sign informed consent.
You have no performance status.
You must have a life expectancy of at least 6 months.
You are fluent in the language in which the standardized tests will be administered.
You are of childbearing potential and must be practicing a highly effective medically acceptable method of contraception (as defined in section 8.4.4.1), including abstinence; hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; or vasectomy (partner), for at least 1 month before the screening visit and for 1 month after the last dose of study medication
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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