Interventional Not yet recruiting Phase 2
NCT07457671 on ClinicalTrials.gov
TAR-0520 Gel in Hand and Foot Syndrome
Official title: A Phase 2a Exploratory Study of TAR-0520 Gel in Prevention of Hand and Foot Syndrome
- Sponsor: Tarian Pharma
- Enrollment: 25 (Estimated)
- Study start: 2026-03-01 (Estimated)
- Primary completion: 2027-03-01 (Estimated)
- Study completion: 2027-06-01 (Estimated)
- Allocation: N/a
- InterventionModel: Single Group
- InterventionModelDescription: Intra-individual comparison
- Masking: None
- PrimaryPurpose: Prevention
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
Intervention / Treatment
- Drug: TAR-0520 gel
Primary Outcome Measures
- Advers events (Baseline, Day 1 of each Cycle ( Cycle1,2,3,4 and 5), each Cycle duration is 21 days)
Countries
France
Locations and Investigators
- Instiut Paoli-Calmettes, Marseille, France