A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2007

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Head and Neck Cancer
Interventions
DRUG

Placebo

Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.

DRUG

palifermin

120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Swedish Orphan Biovitrum

INDUSTRY