Ireland
--:--IST
Starting soon Phase 2

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

NCT07082764 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2025-09-01
Last updated
2025-07-24

Condition(s) studied

Chemotherapy Induced Peripheral Neuropathy

Investigational drug(s) / intervention(s)

Brimonidine gelNo intervantion

Brimonidine gel: TAR-0520 gel

No intervantion: No treatment

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Number of treatment related local adverse events — From Baseline up to the end of 12 taxane perfusions
    Treatement related local adverse events inluding erythema, oedema, pruritus

Trial sites (1)

FacilityCityRegionStatus
Institut Paoli-Calmettes Marseille France

More Tarian Pharma trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07082764 on ClinicalTrials.gov ↗ ← All trials in France