Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT00531934
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2007-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: