Clinical Research Directory

TAR-0520 Gel in Hand and Foot Syndrome

Sponsor: Tarian Pharma

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.

Official title: A Phase 2a Exploratory Study of TAR-0520 Gel in Prevention of Hand and Foot Syndrome

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Interventions

Locations (1)