The aim of this study is to evaluate the safety and efficacy of ATH008 cream in patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy. In part I, the safety and plasmatic levels of the active ingredient and its metabolite will allow to determine the most appropriate and beneficial dose for the second part of the study. In Part II, the efficacy of ATH008 cream in reducing the number of patients presenting PPES grade 2/3 secondary to capecitabine therapy following a four times daily application will be tested.
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Efficacy of ATH008 cream in reducing the number of subjects presenting PPES grade 2/3 secondary to capecitabine therapy
Timeframe: minimum every 21 days, maximum of 4 capecitabine cycles, followed by a safety observation period of 14 days
Safety of ATH008 cream in patients presenting PPES secondary to capecitabine therapy
Timeframe: minimum every 21 days, maximum of 4 capecitabine cycles, followed by a safety observation period of 14 days
Plasmatic levels of ATH008 cream when given topically
Timeframe: blood sampling at specific timepoints (Pre-dose, Day 1 and Day 21)