Safety and Efficacy Placebo Controlled Study of ATH008 Cream in PPES Patients Secondary to Capecitabine
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Advancell - Advanced In Vitro Cell Technologies, S.A.