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Topical Cream for Peripheral Neuropathy

Phase 2
Recruiting
Research Sponsored by WinSanTor, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo chemotherapy for an advanced or metastatic (stage 3 or 4) solid tumor with carboplatin and paclitaxel for 6 cycles of treatment.
ECOG Performance Status (PS) of 0, 1, or 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that involves a cream applied daily. The cream will be tested for safety and how well it works. The trial will last for up to 24 weeks.

Who is the study for?
Adults over 18 with advanced solid tumors undergoing chemotherapy (carboplatin and paclitaxel) can join. They must be able to fill out questionnaires, have a life expectancy of at least 6 months, an ECOG status of 0-2, and use effective contraception. Excluded are those with pre-existing neuropathy not from chemo, certain health conditions or treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing WST-057, a topical treatment for chemotherapy-induced peripheral neuropathy against a placebo. Participants will apply it daily while receiving six cycles of carboplatin and paclitaxel chemotherapy over up to 24 weeks in this randomized, double-blind study.See study design
What are the potential side effects?
Potential side effects may include skin reactions where WST-057 is applied. Since it's being compared to a placebo which has no active ingredients, any additional side effects would likely be related to individual sensitivities or underlying conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am set to receive 6 cycles of chemotherapy with carboplatin and paclitaxel for my advanced cancer.
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I can care for myself and am up and about more than half of my waking hours.
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I am over 18 years old.
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I am set to receive chemotherapy with carboplatin and paclitaxel for my advanced cancer, and may also get Avastin or Keytruda.
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I can take care of myself and am up and about more than half of my waking hours.
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I am not able to have children due to surgery or menopause, or I am using effective birth control.
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I agree to use contraception during the study if I have sex with a woman who can get pregnant.
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My diabetes treatment has been stable for over 2 months and is not expected to change.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 weeks or 24 weeks for subjects on a chemotherapy dose delay
This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 weeks or 24 weeks for subjects on a chemotherapy dose delay for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
+3 more
Secondary outcome measures
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.
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: WST-057 ActiveExperimental Treatment1 Intervention
Participants will apply 4 mL QD WST-057 Active topical solution.
Group II: PlaceboExperimental Treatment1 Intervention
Participants will apply 4 mL QD Placebo topical solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

WinSanTor, IncLead Sponsor
3 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
58 Patients Enrolled for Peripheral Neuropathy
Angela HansenStudy DirectorWinSanTor, Inc
3 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
58 Patients Enrolled for Peripheral Neuropathy
Marian Ijzerman, Ph.DStudy DirectorWinSanTor, Inc

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05488873 — Phase 2
Peripheral Neuropathy Research Study Groups: WST-057 Active, Placebo
Peripheral Neuropathy Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05488873 — Phase 2
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488873 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacant slots available for participants in this study?

"Based on the data hosted by clinicaltrials.gov, this trial is presently inactive; it was posted on August 15th 2022 and updated most recently on August 3rd 2022. However, 161 other medical studies are actively accepting patients right now."

Answered by AI

Has the FDA certified WST-057 as clinically effective?

"The safety of WST-057 Active has been evaluated as a 2 on our 1 to 3 scale since the clinical trial is in its Phase 2, with some data indicating safety but no evidence yet demonstrating efficacy."

Answered by AI

What is the primary aim of this clinical experiment?

"The primary assessment for this trial, which will span 19 or 24 weeks depending on the chemotherapy dose delay per patient, is Treatment-Emergent Adverse Events as evidenced by hematology and chemistry blood tests. Secondary measurements include Intraepidermal Nerve Fiber Density (IENFD), Chemotherapy dose modifications with median duration of delays calculated in days, and Visual Analogue Score (VAS) based on self-reported pain ratings from 0 to 100 mm."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~7 spots leftby Apr 2024