Non-small-Cell Lung Cancer Clinical Trial
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)
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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