Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy

NCT07082764 | Not Yet Recruiting Phase 2

• 2 other identifiers: TARIAN 0142025-521674-33-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Taxane -induced peripheral neuropthy (TIPN) and nail toxicites are frequent side effects of taxane therapy in breast cancer patients.. TIPN involves the hands and the feet ,its symptoms comprise numbness,tingling,altered touch sensation, impaired vibration, parasthesia and dysesthesias induced by touch, warm or cool temperatures. This study investigate the preventive effect of TAR-0520 gel on TIPN and on nail toxicity. Breast cancer patients under taxanes therapy will apply TAR-0520 Gel to one hand and the homolateral foot including fingers and toes. Other hand and foot will be untreated and will serve as control. Patients will be followed during the 12 cycles of taxane therapy. Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaires administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of taxane nail toxicity will include a clinical grading by a nurse and a patient questionnaire.

Conditions

Chemotherapy Induced Peripheral Neuropathy

Keywords

taxane-induced peripheral neuropathy; taxane-induced nail toxicities

Outcome Measures

Primary Outcomes (1)

• Number of treatment related local adverse events

  Treatement related local adverse events inluding erythema, oedema, pruritus

  From Baseline up to the end of 12 taxane perfusions

Secondary Outcomes (5)

• CTCAE grade of peripheral neuropathy

  From Baseline up to the end of 12 taxane perfusions

• Instrumental objective measures of TIPN - heat thresold

  At Baseline and after 6th and 12th taxane perfusion

• Instrumental objective measures of TIPN - cold thresold

  At Baseline and after 6th and 12th perfusions

• Instrumental objective measures of TIPN - vibration treshold

  At Baseline and after 6th and 12th perfusion

• Instrumental objective meeasures of TIPN - electrochemical skin conductance (ESC)

  At Baseline and after 6th and 12 perfusion

Other Outcomes (1)

• Nail toxicity grading

  At Baseline and before 4th and 12th perfusion

Study Arms (1)

Intra-individual active comparator vs no intervention

EXPERIMENTAL

Tar-0520 gel will be applied to one hand and to homolateral foot ,other hand and foot will be not treated and will serve as control

Drug: Brimonidine gel; Other: No intervantion

Interventions

Brimonidine gel DRUG

TAR-0520 gel

Intra-individual active comparator vs no intervention

No intervantion OTHER

No treatment

Intra-individual active comparator vs no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, who is at least 18 years of age or older
• Patients with clinical diagnosis of breast cancer
• Patients planned to be treated with paclitaxel or docetaxel
• Patients who can understand and sign the Informed Consent Form
• Patients who can apply the study gel by himself /herself or has a giver that can apply the product.
• Female patients of childbearing potential who agree to use a highly effective method of contraception throughout the study

You may not qualify if:

• Patient already treated with taxanes or other chemotherapies known to induce neuropathies
• Patient with previously diagnosed peripheral neuropathy
• Patient with concomitant therapies known to induce neuropathies
• Patient treated for neuropathic pain
• Patient with comorbid factors known to induce neuropathies (such as Diabetes, Alcoholism, HIV, Peripheral vascular disease, Vitamin B deficiencies)
• Patient currently receiving monoamine oxidase (MAO) inhibitors therapy or patients on antidepressants which affect noradrenergic transmission e.g. tricyclic antidepressants and mianserin (as mentioned in the current topical brimonidine labeling of approved products).
• Patient who will not be able to follow the protocol for physical or psychological reasons
• Patient with history of skin disorders, significant skin disease, irritated skin or open wounds within the same body areas planned for the IMP application.
• Known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label)
• Female who is pregnant or lactating
• Female who intends to conceive a child during the clinical trial

Sponsors & Collaborators

• Tarian Pharma: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Study Officials

• Janusz M Czernielewski, MD, PhD

  Tarian Pharma

  STUDY DIRECTOR

Central Study Contacts

Janusz M Czernielewski, MD

CONTACT

+33680338274; janusz.czernielewski@tarianpharma.com

Alexandra MS Lamquin, PharmD

CONTACT

+33623363962; alexandra.lamquin@tarianpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: intra-individual comparaison

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)