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| Sponsor: | Allergan |
|---|---|
| Information provided by: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00343187 |
Purpose
The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face
| Condition | Intervention | Phase |
|---|---|---|
|
Rash Non-Small-Cell Lung Cancer |
Drug: ACZONE (dapsone) Gel, 5% Drug: Vehicle Control |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Randomized, Double-Blind, Parallel Design Study to Evaluate ACZONE™ (Dapsone) Gel, 5% As a Treatment For Rash Related to the Human Epidermal Growth Factor Receptor 1 (HER1)/Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor Tarceva® (Erlotinib) |
| Enrollment: | 40 |
| Study Start Date: | June 2006 |
| Study Completion Date: | July 2007 |
This will be a randomized, double-blind, parallel design study in subjects treated with Tarceva for non-small cell lung cancer (NSCLC) who subsequently develop a rash suspected to be related to Tarceva. Only subjects who are not glucose-6-phosphate dehydrogenase (G6PD) deficient, and who have locally advanced or metastatic NSCLC and have failed at least 1 prior chemotherapy regimen indicated for Tarceva treatment will be included. Subjects will be screened and consented for the study within 3 days of initiating Tarceva therapy and will be instructed to contact the Investigator immediately when signs or symptoms of rash appear on the face. Subjects will be enrolled into the study only if a rash develops on the face and it has been confirmed and evaluated against eligibility criteria for the study.
Once enrolled, subjects will be randomly assigned to apply either ACZONE or placebo to the rash-affected areas of the face. Subjects will apply ACZONE / placebo treatment for 8 weeks, even if symptoms of the rash resolve completely. Specific efficacy assessments will include lesion counts, plaque area, erythema assessment, and pruritus assessment. Rash characteristics will be monitored using National Cancer Institute (NCI) Common Terminology Criteria Adverse Event (CTCAE) version 3.0 terms and severity descriptions and percentage of facial surface area (FSA) affected. Investigators will evaluate the subject's overall response to treatment according to a standardized multiple choice question. Throughout the study, photographs of the face will be taken.
Safety will be followed for 10 weeks (8 weeks of therapy + 2 weeks of follow-up) by monitoring adverse events, concomitant medications, and chemistry and hematology parameters. Plasma dapsone and N-acetyl dapsone concentrations will be measured to determine systemic exposure to the study treatment. Steady state plasma concentrations of erlotinib will also be measured before and after initiating the study treatment to determine any potential effects of ACZONE on pharmacokinetics of Tarceva.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible for the study, subjects must fulfill all of the following criteria:
Present with acute signs and symptoms of rash on the face that meet the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
Contacts and Locations| United States, Illinois | |
| Northwestern University Robert H. Lurie Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60611-2941 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Study Director: | Steven Garrett, MS, DDS | QLT USA, Inc |
More Information
| Study ID Numbers: | ACZ EGFR 01 |
| Study First Received: | June 20, 2006 |
| Last Updated: | September 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00343187 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Tarceva Rash EGFR-1 Rash erlotinib |
Aczone Dapsone Non-small Cell Lung Cancer subjects treated with Tarceva for non-small cell lung cancer (NSCLC) who subsequently develop a rash suspected to be related to Tarceva |
|
Thoracic Neoplasms Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Anti-Bacterial Agents Exanthema Antimalarials Antiparasitic Agents Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Dapsone |
Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Skin Diseases Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Carcinoma Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Leprostatic Agents |