Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454779
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2007-03-29
Brief Title:
PARTNER Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Open-Label Controlled Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-09
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 is a randomized open-label 2-arm controlled phase 2 multi-center estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm This study will be conducted in the United States Approximately 150 subjects with histologically or cytologically confirmed metastatic andor recurrent SCCHN
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