Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393822
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2006-10-26
Brief Title:
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced Colon Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin Recombinant Human Keratinocyte Growth Factor for Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced Colon Cancer Receiving 5-FU and Leucovorin as Adjuvant Therapy
Status:
COMPLETED
Status Verified Date:
2014-07
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 safety and tolerability of palifermin recombinant human keratinocyte growth factor rHuKGF in reducing the incidence of oral mucositis in subjects with stage 2B and 3 locally advanced colon cancer receiving chemotherapy as an adjuvant treatment for their disease
Detailed Description:
This study is being conducted to determine whether administration of a single IV dose of palifermin 3 days before initiation of chemotherapy and 3 days before each subsequent treatment cycle would reduce the incidence of oral mucositis and to evaluate the safety profile in the subject population This study will evaluate the efficacy of palifermin in reducing the incidence of grade 2 OM in subjects with stage 2B or stage 3 locally advanced colon cancer undergoing adjuvant chemotherapy with 5-FU and leucovorin in cycle 1 This study will also assess the safety and tolerability of palifermin administered as a single IV dose before each cycle of 5-FU and leucovorin evaluate the effect of palifermin on patient-reported mouth and throat soreness the incidence of grade 2 oral mucositis in cycle 2 the duration of grade 2 oral mucositis 5-FU dose reductionsdelays and the long-term effects of palifermin on disease outcome and survival
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