Chemotherapy-induced Peripheral NeuropathyPhase 2NCT05488873
A Study of Topical Pirenzepine or Placebo in Oncology Patients With Chemotherapy Induced Peripheral Neuropathy
A Phase 2 study testing WST-057 Active in people with Chemotherapy-induced Peripheral Neuropathy, run by WinSanTor, Inc at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- WST-057 Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ages > 18 years and older.
- Scheduled to undergo chemotherapy for an advanced or metastatic (stage 3 or 4) solid tumor with carboplatin and paclitaxel for 6 cycles of treatment. Treatment with immunotherapy agents Avastin (bevacizumab) and/or Keytruda (pembrolizumab) is permitted.
- Ability to sign informed consent and understand the nature of a placebo-controlled trial.
- ECOG Performance Status (PS) of 0, 1, or 2.
- Ability to complete patient reported outcome questionnaires by themselves.
- Life expectancy ≥ 6 months
Show all 10Show fewer
- Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or 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. If access or use of a highly effective medically acceptable method of contraception is not achievable, then a combination of barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge) is acceptable. Eligible female subjects must also have a negative pregnancy test at the screening and baseline visit.
- Males must agree to the use an acceptable form of contraception (as defined in section 8.4.4.1) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study (e.g., male condom with diaphragm, male condom with cervical cap, or male condom in association with spermicide).
- If diabetic, be on stable antidiabetic treatment (> 2 months prior to screening) (oral or injectable antidiabetic therapy and/or lifestyle) that is not anticipated to change during the course of the study, except if medically required.
- Fluency (oral and written) in the language in which the standardized tests will be administered
Who cannot join
- Pre-existing history (with or without current symptoms) in medical history of any type of peripheral neuropathy due to any cause other than prior chemotherapy (diabetes, alcohol, toxins, neurotoxic treatments, hereditary, autoimmune, etc.).
- Anyone with prior history of severe paclitaxel hypersensitivity (including anaphylaxis) should be excluded from study enrollment. Pre-treatment is per local standard of care guidelines to prevent a paclitaxel hypersensitivity reaction. Absolute Neutrophil Count (ANC) must be at least 1500 cells/mm3 prior to paclitaxel treatment.
- Currently taking regular pain medications i.e., gabapentin, pregabalin, amitriptyline or duloxetine. (Exception: opioids, given for the short-term treatment i.e., malignant pain is acceptable. Opioids prescribed for neuropathic pain is excluded).
- Clinically significant active macrovascular disease, including a) myocardial infarction or cerebrovascular event in the prior 6 months, b) angioplasty or stenting of coronary arteries or coronary artery bypass surgery within the past < 12 months (valve replacements are permitted as long as patient has fully recovered from the surgery), c) diagnosis of congestive heart failure of any NY heart class I-IV, d) stable or progressive angina pectoris.
- Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
- Vitamin E supplementation (2R-α-tocopherol or equivalent) for any reason > 225 IU (approximately 150mg)/day ≤ 30 days prior to randomization.
Show all 39Show fewer
- Any of the following: pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception (as defined in section 8.4.4.1).
- Head or neck cancers.
- Scheduled to undergo radiation therapy while on study.
- History of hemorrhagic stroke.
- Proliferative retinopathy or maculopathy requiring acute treatment.
- Patients requiring dialysis.
- Presence of clinically significant peripheral or autonomic neuropathy.
- Current use local (topical) anesthetics or analgesics including lidocaine, capsaicin, cannabinoid (CBD) oil/products, or compounded topical pharmaceutical agents.
- Uncontrolled treated/untreated hypertension (systolic blood pressure [BP] ≥ 180 or diastolic BP ≥ 100 at screening).
- Amputations of lower extremities or presence of foot ulcers.
- Uncontrolled or untreated hypothyroidism.
- Active and/or systemic infections (e.g., HIV, hepatitis C, tuberculosis, syphilis), or a history of severe infection during the 30 days prior to screening.
- Clinically significant gastric emptying abnormality (e.g., severe gastroparesis).
- Clinically significant urinary retention or an enlarged prostate.
- Uncontrolled glaucoma.
- Other clinically significant, active or progressive (over the past 12 months) disease of the cardiovascular, gastrointestinal, pulmonary, renal, dermatologic, neurologic, genitourinary, endocrine, rheumatologic or hematologic systems that, in the opinion of the Investigator, would compromise the subject's participation in the study, might confound the results of the study, or pose additional risk in administering the study drug.
- New treatment with (< 3 months) vitamins and supplements at the discretion of the PI.
- Known or suspected history of alcohol or substance abuse (a stable and regular use of medical marijuana for non-neuropathic indications is acceptable).
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding of or cooperation with the study.
- Women of childbearing potential must have a negative pregnancy test at screening and baseline and must agree to use adequate contraceptive methods (as defined in section 8.4.4.1) during the study and for 1 month after the last dose of study drug (see inclusion criterion 7).
- History of allergy or hypersensitivity to anticholinergics or any of the components of the investigational product formulations (pirenzepine, coconut oil, ethanol, dimethyl sulfoxide (DMSO), surfactants, propylene glycol, etc.).
- History of sensitive skin, as defined by a requirement to use soap and skin products formulated for "sensitive skin," as determined by the Investigator.
- Currently taking any medicines to treat overactive bladder (anticholinergic agents, such as Gelnique), or antispasmodics.
- Inability to perform screening or baseline assessments.
- Patients with any condition that could potentially interfere with the conduct of the study or confound efficacy evaluations, including the following as specified in numbers 31 through 38 below:
- Presence of pain, or any masquerading symptoms presenting as neuropathy including central pain, radiculopathy, painful arthritis, etc., that could interfere with the interpretation of the neuropathy endpoint assessments at the discretion of the PI.
- Major skin or soft-tissue lesions in the dosing from below the knees to the bottom of both feet, and hands), small lesions (i.e., size of coin) are acceptable. However, topical application of study drug to these areas should be avoided.
- Exposure to an experimental drug, experimental biologic, or experimental medical device within 3 months before screening.
- Any open wound(s) and/or sunburn(s) in the dosing area. Subjects who have a wound and/or sunburn at screening that is anticipated to resolve before day -1 can be enrolled.
- History of a serious skin disease (as determined by the Investigator), such as skin cancer, psoriasis, stasis dermatitis or eczema.
- Receipt of a tattoo in the dosing area within 12 months of dosing.
- Known or untreated Lyme disease.
- Any abnormal or clinically significant lab or test result, collected from the Screening or Baseline visits that in the Investigator's opinion would not make the subject an ideal participant in this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: 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
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).
Read the detailed description
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). A Data Safety Monitoring Committee will review the safety data for all patients upon the completion of the first 10 patients. An interim analysis for safety and futility (primary and secondary endpoints) will be conducted after the first 20 subjects complete the trial. Based on this analysis an additional 20 subjects will be randomized and the power assessed. Depending on the statistical power after 40 subjects complete, a determination will be made as to whether or not to continue the recruitment up to a maximum of 60 subjects' completing the study.
- Being tested
- WST-057 Active, Placebo
- Keywords
- Oncology, Peripheral Neuropathy, Chemotherapy, Carboplatin/Paclitaxel
- Medical subject headings
- Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WST-057 ActiveDrug
Also called Active
WST-057 Topical Solution
PlaceboDrug
Matching Placebo Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Participants will apply 4 mL QD Placebo topical solution Receives: Drug: Placebo |
| WST-057 Active | Experimental | Participants will apply 4 mL QD WST-057 Active topical solution. Receives: Drug: WST-057 Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by hematology and chemistry blood tests.
Safety will be assessed by observing changes in patients' blood tests when compared to normal lab values/ranges after once daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAEv5.0 will be reported.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
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).
Safety will be assessed by observing changes in vitals signs (from baseline) in patients after daily topical doses of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Incidence of Treatment-Emergent Adverse Events as assessed by ECG (measuring P Wave, QRS complex, QT interval)
Safety will be assessed by observing changes in ECG parameters (from baseline) in patients after daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Incidence of Treatment-Emergent Adverse Events as assessed by a dermal assessment (Draize score (scale 0.0-4.0) of the dosing area
Dermal safety will be assessed by observing changes in dermal scores (from baseline) in patients after daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Incidence of Treatment-Emergent Adverse Events as assessed by physical examination
Safety will be assessed by observing changes in physical examination findings (from baseline) in patients after daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Incidence of Treatment-Emergent Adverse Events as assessed by tumor evaluation using RECIST v1.1
Safety will be assessed by observing changes in tumor evaluation of radiology using RECIST v 1.1(from baseline) in patients after daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Secondary outcomes (18)
Visual Analogue Score (VAS)
Visual Analogue Scale (VAS) is a patient-reported pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single mark placed at one point along a horizontal line 100 mm in length that represents a continuum between the two ends of the scale - "no pain" on the left end of the scale and the "worst imaginable pain" on the right end of the scale.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Neuropathy Total Symptom Score-6 (NTSS-6)
The NTSS-6 is a validated (proctored) patient reported outcome tool that assesses intensity and frequency of different pain modalities (aching, burning, prickling \& lancinating pain, numbness and allodynia) in patients with neuropathy.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-13 (FACT/GOG-Ntx-13)
The FACT/GOG-Ntx-13 measures the severity and impact of symptoms of neuropathy over the past 7 days. Scores range from 0 to 48, with lower scores indicating more severe neurotoxicity.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Patient-Reported Outcomes Measurement Information System (PROMIS)-physical function (short form)
PROMIS Physical Function (PROMIS PF) measures the outcome of patients with musculoskeletal disorders by assessing physical function through a grading scale of activities of daily living. The PROMIS Short Form v2.0 - Physical Function 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It has a recall period of the past seven days and includes a 5-point scale with three sets of response options. Six capability-framed questions are administered with one set of response options, "Without any difficulty" to "Unable to do," and two disability framed-questions are administered with two sets response options, "Not at all" to "Cannot do" and "No difficulty at all" to "Can't do because of health". Scores on the PROMIS Short Form v2.0 - Physical Function 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Thermal Quantitative Sensory Testing (Cold)
Quantification of thermal thresholds has proven to be useful for the evaluation of small-fiber function. QST for cold perception thresholds on both great toes will be assessed. A reduction in QST thermal threshold has shown to have high diagnostic value in subjects with chemotherapy-associated neuropathies.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Utah Early Neuropathy Score (UENS)
UENS is a simple, rapid, and reproducible test targeted to detect early sensory peripheral neuropathy. It includes motor examination, pin sensation, allodynia, hyperesthesia, large-fiber sensation, and deep tendon reflexes. The sensations are reported on 0-, 1-, or 2-point scoring for normal, reduced or absent vibration or reflexes.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Activity and Fear of Falling Measurement (Short FES-I)
The Short FES-I is a shortened version of the falls efficacy scale to assess fear of falling. A 7-question method to give a total that will range from 7 (no concern about falling) to 28 (severe concern about falling).
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Intraepidermal Nerve Fiber Density
IENF density (IENFD) is the gold standard for the diagnostic of small fiber pathology and for measuring small fiber neuropathy.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Hand Dexterity
The grooved pegboard test, a timed, validated, sensory-motor, speed test of a patient's ability to place pegs into a slotted board, will be used to quantify the potential changes in hand dexterity in this patient population.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by percentage of patients requiring dose reductions of chemotherapy.
Efficacy will be assessed by observing the number of patients requiring dose reductions of chemotherapy due to sensory peripheral neuropathy.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by the percentage of patients requiring dose delay of chemotherapy.
Efficacy will be assessed by observing the number of patients requiring dose delays of chemotherapy due to sensory peripheral neuropathy.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by median duration of delays (days) between chemotherapy treatments.
Efficacy will be assessed by calculating the median duration of delays (days) between chemotherapy treatments.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by the percentage of patients requiring replacement or change to initially prescribed chemotherapy (carboplatin/paclitaxel combination).
Efficacy will be assessed by observing the number of patients requiring replacement or change to initially prescribed chemotherapy.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by the percentage of patients stopping chemotherapy before treatment is complete. chemotherapy (carboplatin/paclitaxel combination).
Efficacy will be assessed by observing the number of patients stopping chemotherapy before treatment is complete due to sensory peripheral neuropathy.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dose limiting neuropathy as assessed by decrease in chemotherapy-induced peripheral sensory neuropathy ≥ Grade 3.
Efficacy will be assessed by change in chemotherapy-induced peripheral sensory neuropathy ≥ Grade 3 as assessed by the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dose limiting neuropathy as assessed by decrease in percentage of patients with sensory peripheral neuropathy ≥ Grade 3
Efficacy will be assessed by a change in the percentage of patients with sensory peripheral neuropathy ≥ Grade 3.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dose limiting neuropathy as assessed by increase in time to onset of sensory peripheral neuropathy ≥ Grade 3.
Efficacy will be assessed by a change in the time to onset of sensory peripheral neuropathy ≥ Grade 3; using incidences of the adverse event while the patient was receiving chemotherapy.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dose limiting neuropathy as assessed by decrease in duration of sensory peripheral neuropathy ≥ Grade 3.
Efficacy will be assessed by a change in the duration of sensory peripheral neuropathy ≥ Grade 3; using the time from onset of grade 3+ neuropathy.
Measured: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start22 Nov 2022
- Primary completion26 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WinSanTor, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela Hansen, Study director, WinSanTor, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488873
- Sponsor's protocol ID
- WST-PZP-005
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05488873
- Acronym / sponsor ID
- WST-PZP-005
- Keywords
- Oncology, Peripheral Neuropathy, Chemotherapy, Carboplatin/Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- WinSanTor, IncIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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). A Data Safety Monitoring Committee will review the safety data for all patients upon the completion of the first 10 patients. An interim analysis for safety and futility (primary and secondary endpoints) will be conducted after the first 20 subjects complete the trial. Based on this analysis an additional 20 subjects will be randomized and the power assessed. Depending on the statistical power after 40 subjects complete, a determination will be made as to whether or not to continue the recruitment up to a maximum of 60 subjects' completing the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboParticipants will apply 4 mL QD Placebo topical solution |
| WST-057 Active | Experimental | Drug: WST-057 ActiveParticipants will apply 4 mL QD WST-057 Active topical solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females, ages > 18 years and older.
- Scheduled to undergo chemotherapy for an advanced or metastatic (stage 3 or 4) solid tumor with carboplatin and paclitaxel for 6 cycles of treatment. Treatment with immunotherapy agents Avastin (bevacizumab) and/or Keytruda (pembrolizumab) is permitted.
- Ability to sign informed consent and understand the nature of a placebo-controlled trial.
- ECOG Performance Status (PS) of 0, 1, or 2.
- Ability to complete patient reported outcome questionnaires by themselves.
Key exclusion criteria (39 listed)
- Pre-existing history (with or without current symptoms) in medical history of any type of peripheral neuropathy due to any cause other than prior chemotherapy (diabetes, alcohol, toxins, neurotoxic treatments, hereditary, autoimmune, etc.).
- Anyone with prior history of severe paclitaxel hypersensitivity (including anaphylaxis) should be excluded from study enrollment. Pre-treatment is per local standard of care guidelines to prevent a paclitaxel hypersensitivity reaction. Absolute Neutrophil Count (ANC) must be at least 1500 cells/mm3 prior to paclitaxel treatment.
- Currently taking regular pain medications i.e., gabapentin, pregabalin, amitriptyline or duloxetine. (Exception: opioids, given for the short-term treatment i.e., malignant pain is acceptable. Opioids prescribed for neuropathic pain is excluded).
- Clinically significant active macrovascular disease, including a) myocardial infarction or cerebrovascular event in the prior 6 months, b) angioplasty or stenting of coronary arteries or coronary artery bypass surgery within the past < 12 months (valve replacements are permitted as long as patient has fully recovered from the surgery), c) diagnosis of congestive heart failure of any NY heart class I-IV, d) stable or progressive angina pectoris.
- Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WST-057 ActiveAlso: ActiveWST-057 Topical Solution | Drug | WST-057 Active |
| PlaceboMatching Placebo Topical Solution | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by hematology and chemistry blood tests.
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Safety will be assessed by observing changes in patients' blood tests when compared to normal lab values/ranges after once daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAEv5.0 will be reported.
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).
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Safety will be assessed by observing changes in vitals signs (from baseline) in patients after daily topical doses of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Incidence of Treatment-Emergent Adverse Events as assessed by ECG (measuring P Wave, QRS complex, QT interval)
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Safety will be assessed by observing changes in ECG parameters (from baseline) in patients after daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Incidence of Treatment-Emergent Adverse Events as assessed by a dermal assessment (Draize score (scale 0.0-4.0) of the dosing area
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dermal safety will be assessed by observing changes in dermal scores (from baseline) in patients after daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Incidence of Treatment-Emergent Adverse Events as assessed by physical examination
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Safety will be assessed by observing changes in physical examination findings (from baseline) in patients after daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
Incidence of Treatment-Emergent Adverse Events as assessed by tumor evaluation using RECIST v1.1
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Safety will be assessed by observing changes in tumor evaluation of radiology using RECIST v 1.1(from baseline) in patients after daily dosing of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be reported.
18 secondary outcomes
Visual Analogue Score (VAS)
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Neuropathy Total Symptom Score-6 (NTSS-6)
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-13 (FACT/GOG-Ntx-13)
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Patient-Reported Outcomes Measurement Information System (PROMIS)-physical function (short form)
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Thermal Quantitative Sensory Testing (Cold)
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Utah Early Neuropathy Score (UENS)
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Activity and Fear of Falling Measurement (Short FES-I)
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Intraepidermal Nerve Fiber Density
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Hand Dexterity
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by percentage of patients requiring dose reductions of chemotherapy.
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by the percentage of patients requiring dose delay of chemotherapy.
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by median duration of delays (days) between chemotherapy treatments.
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by the percentage of patients requiring replacement or change to initially prescribed chemotherapy (carboplatin/paclitaxel combination).
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Chemotherapy dose modifications as assessed by the percentage of patients stopping chemotherapy before treatment is complete. chemotherapy (carboplatin/paclitaxel combination).
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dose limiting neuropathy as assessed by decrease in chemotherapy-induced peripheral sensory neuropathy ≥ Grade 3.
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dose limiting neuropathy as assessed by decrease in percentage of patients with sensory peripheral neuropathy ≥ Grade 3
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dose limiting neuropathy as assessed by increase in time to onset of sensory peripheral neuropathy ≥ Grade 3.
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Dose limiting neuropathy as assessed by decrease in duration of sensory peripheral neuropathy ≥ Grade 3.
Time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Hansen study director
WinSanTor, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WST-057 Active in people with Chemotherapy-induced Peripheral Neuropathy, run by WinSanTor, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events as assessed by hematology and chemistry blood tests. (time frame: 19 weeks or 24 weeks for subjects on a chemotherapy dose delay). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.