TAR-0520 Gel in Hand and Foot Syndrome

NCT07457671 | Not Yet Recruiting Phase 2

• 2 other identifiers: TARIAN0082025-524008-32-00
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Hand and Foot Syndrome (HFS) is a weii-established and frequent cutaneous adverse event of capecitabine used in the treatment of different cancers.HFS is charectirized by a variety of symptoms ranging from mild discomfort to a painful sensation of palms and sols that could limit functionality and hamper patients on their daily activities. The aim of this study is to explore the TAR-0520 gel safety and preventive efficacy of HFS in patients with colorectal and breast cancer patients treated with capecitabine. Is the product well tolerated locally and systemically ? Is the product reducing frequency and severity of HFS ? Is product improving Quality of Life (QoL) of treated patients ? Each patient will receive the active TAR-0520 gel and they will apply it to both hands,twice daily. Applications will be done 1 hour before each morning and evening capecitabine oral intake. Feet will be not treated and will serve as controls. In total , this study will follow patients during 4 capecitabine Cycles (each Cycle=21 days) for a total of 12 weeks. Clinical evaluations will take place at Day1 of each Cycle and will be conducted separetaly on hands and feet.

Conditions

Hand and Foot Syndrome

Keywords

Hand and Foot Syndrome; Prevention of Hand and Foot Syndrome

Outcome Measures

Primary Outcomes (1)

• Advers events

  Baseline, Day 1 of each Cycle ( Cycle1,2,3,4 and 5), each Cycle duration is 21 days

Secondary Outcomes (1)

• Severity of HFS on hands and foot

  Baseline, Day 1 of each Cycle (Cycle 1,2,3,4 and 5) each Cycle duration is 21 days

Other Outcomes (1)

• HFS clinical grading

  Baseline,Day 1 of each Cycle ( Cycle 1,2,3,4 and 5), each cycle duration is 21 days

Study Arms (1)

TAR-0520 gel

EXPERIMENTAL

Treatment of the hands

Drug: TAR-0520 gel

Interventions

TAR-0520 gel DRUG

hands treatment

TAR-0520 gel

Eligibility Criteria

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

You may qualify if:

• Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine
• at a dose \> 1000mg/m² twice daily every 2 out of 3 weeks as single agent chemotherapy
• Patients with life expectancy graeter than 12 weeks

You may not qualify if:

• Patient with medical history of capecitabine treatment
• patient with pre-existing neuropathy confounding assessement of HFS
• Patient with Raynaud's syndrome or other vascular peripheral disorders
• Patient with dermatological lesions on hands or foot

Sponsors & Collaborators

• Tarian Pharma: lead

Study Sites (1)

Instiut Paoli-Calmettes

Marseille, 13009, France

Location

MeSH Terms

Conditions

Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Central Study Contacts

Janusz M Czernielewski, MD

CONTACT

+33680338274; janusz.czernielewski@tarianpharma.com

Alexandra Lamquin, PhD

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 comparison

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)