NCT00131638 - A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer | Biotech Hunter

Enrollment

241

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

November 30, 2007

Study Completion Date

July 31, 2016

Conditions

Head and Neck Cancer

Interventions

DRUG

Placebo

Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.

DRUG

Palifermin

Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course