CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 enrolled
Drug / intervention
erlotinib [Tarceva] +3 moredrug
Likely dose
erlotinib [Tarceva] 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00718315
NCT00718315Phase 3Completed

A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Hoffmann-La Roche·interventional·Posted Jul 18, 2008·Updated Jan 15, 2015

In Brief

A Phase 3 clinical trial evaluating erlotinib [Tarceva], fusidic acid [Verutex], and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 201 participants across 26 sites.

Detailed Summary

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2008
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.0 years ago

Interventions

erlotinib [Tarceva]drug

150mg po daily

fusidic acid [Verutex]drug

topical, daily for 30 days.

erythromycin [Eritex]drug

topical, daily for 30 days.

Fisiogeldrug

topical, daily for 30 days