Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131638
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2005-07-26
Brief Title:
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin rHuKGF for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and ChemotherapyRTCT
Status:
COMPLETED
Status Verified Date:
2016-12
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:
The purpose of this study is to evaluate the efficacy and safety of palifermin recombinant human keratinocyte growth factor rHuKGF in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease
Detailed Description:
This study is being conducted to evaluate the efficacy of palifermin administered intravenously IV in weekly doses minimum of 7 weekly doses until RT was complete in reducing the incidence of severe World Health Organization WHO grade 3 or 4 oral mucositis in subjects with locally advanced HNC receiving RT concurrent with CT RTCT as adjuvant treatment for their disease postoperative setting This study will assess the safety and tolerability of palifermin at the dose of 120 μgkg IV administered weekly minimum 7 weekly doses until RT was complete in this subject population This study will also evaluate the effect of palifermin on the clinical sequelae of severe OM eg average subject-reported mouth and throat soreness MTS score and on RT-induced xerostomia in this population as well as the long-term effects of palifermin on disease outcome and survival in this population
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