Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412217
Status:
TERMINATED
Last Update Posted:
2016-11-25
First Post:
2006-12-15
Brief Title:
A Study of Erlotinib Tarceva in Participants With Resected Head and Neck Squamous Cell Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Phase III Randomized Controlled Trial of Erlotinib Tarceva as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated because recruitment was too slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This two-arm study will compare the efficacy and safety of erlotinib Tarceva versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone Participants will be randomized to receive either erlotinib 150 milligrams mg orally PO once daily or placebo for 1 year until disease progression or unacceptable toxicity
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-001845-33 | EUDRACT_NUMBER | None | None |