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NOT YET RECRUITING
NCT07082764
PHASE2

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

Sponsor: Tarian Pharma

View on ClinicalTrials.gov

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.

Official title: A Phase 2a Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-01

Completion Date

2026-12-15

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DRUG

Brimonidine gel

TAR-0520 gel

OTHER

No intervantion

No treatment

Locations (1)

Institut Paoli-Calmettes

Marseille, France