Trial intelligence / Profile preview

Preemptive Therapy for Cetuximab-Induced Rash

NCT01874860Phase 2

Key facts

Status
Completed
Start
Aug 2013
Primary completion
Jul 2018
Countries
1
Sponsor
University of Louisville
Modality
Orthosteric Ligands
Conditions
drug eruption
01

Overview

Phase 2, randomised, open-label trial of doxycycline and Alkindi Sprinkle in drug eruption (2 arms), sponsored by University of Louisville. Primary endpoint: Incidence of Rash at 8 weeks. Started Aug 2013; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Extensive Treatment

    Doxycycline + Hydrocortisone + Sunscreen + Moisturizer

  • Standard Care

    Reactive treatment only

03

Who it enrols

Adult patients with colorectal or head and neck cancer scheduled to receive cetuximab, excluding those with prior cetuximab within 6 months or current TKI treatment.

04

Endpoints

Primary

  • Incidence of Rash

Secondary

  • Quality of Life

  • Adherence to treatment regimen

  • Progression Free Survival

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