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Safety and Efficacy Placebo Controlled Study of ATH008 Cream in PPES Patients Secondary to Capecitabine

NCT01316406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2014-01-30

No results posted yet for this study

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.

Conditions

  • Palmar-Plantar Erythrodysesthesia Syndrome

Interventions

DRUG

ATH008

The subject will be incorporated in the study and randomised to ATH008 cream 3% or 8% or ATH008 cream placebo

Sponsors & Collaborators

  • Cromsource

    collaborator INDUSTRY

  • Advancell - Advanced In Vitro Cell Technologies, S.A.

    lead INDUSTRY

Principal Investigators

  • Dr. A. Awada · Jules Bordet Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Belgium
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01316406 on ClinicalTrials.gov