Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343187
Status:
TERMINATED
Last Update Posted:
2011-05-30
First Post:
2006-06-20
Brief Title:
A Phase II Study of ACZONE Dapsone Gel 5 As a Treatment For Tarceva ErlotinibRelated Rash
Sponsor:
Allergan
Organization:
Allergan
Study Overview
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 HER1Epidermal-Growth-Factor-Receptor EGFR Inhibitor Tarceva Erlotinib
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1EGFR inhibitor Tarceva erlotinib who develop a rash on the face
Detailed Description:
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 30 terms and severity descriptions and percentage of facial surface area FSA affected Investigators will evaluate the subjects 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
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 30 terms and severity descriptions and percentage of facial surface area FSA affected Investigators will evaluate the subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None