Palmar-Plantar Erythrodysesthesia Syndrome Clinical Trial
Official title:
A Phase II Placebo Controlled, Multicenter Study to Investigate the Safety and Efficacy of ATH008 Cream in Patients With Palmar-Plantar Erythrodysesthesia Syndrome (PPES) Secondary to Capecitabine Therapy.
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.
This is a Phase II Placebo Controlled, Multicenter Study that will involve up to 114
patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine
therapy. Eligible patients will be enrolled into Part I or Part II of the study.
The first part of the study (Part I) is designed
- to demonstrate the safety of ATH008 cream 1%, 3% and 8% and ATH008 cream placebo,
- to determine the plasmatic levels of the active ingredient and its metabolite after
repeated doses of ATH008 cream 1%, 3% and 8%, and
- to determine the grade of PPES at Day 1 and Day 21 of ATH008 cream treatment Part I
will have four different arms; patients will receive one of the three different doses
of drug product (ATH008 cream 1%, ATH008 cream 3% or ATH008 cream 8%) or placebo
(ATH008 cream placebo) in repeated doses (twice daily) during a period of 21 days.
Patients will continue to be assessed for safety and pharmacokinetics of active ingredient
and its metabolite (Pre-dose, Day 1 and Day 21). Results of Part I will determine the most
appropriate and beneficial dose for the second part of the study.
The second part of the study (Part II) is aimed at demonstrating the safety and 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.
Part II will have three different arms; patients will receive ATH008 cream 3%, 8% or placebo
in repeated doses (four times per day) since appearance of PPES grade 1 until appearance of
grade 2-3 or a maximum of 4 cycles. Patients will continue to be assessed for safety. The
clinical signs will be reported by iconographic register of lesions and pain will be
evaluated using a pain scale. Patient will fill a questionnaire reporting QoL.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment