TAR-0520 Gel in Hand and Foot Syndrome
Starting soon · Phase 2
Conditions studied: Hand and Foot Syndrome
In brief
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.
Key facts
- Study ID
- NCT07457671
- Run by
- Tarian Pharma
- People needed
- 25
- Starts
- 2026-03-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Instiut Paoli-Calmettes — Marseille, France
Full record on ClinicalTrials.gov
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