A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy With Concurrent Chemotherapy
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
To evaluate the safety and tolerability of palifermin when administered at the dose of 120 μg/kg weekly for up to 8 consecutive weeks.
To evaluate safety and tolerability of palifermin when administered at the dose of 120 μg/kg weekly for up to 8 consecutive weeks to patients with locally advanced head and neck cancer (HNC) receiving radiotherapy (RT) with concurrent chemotherapy (CT) as adjuvant treatment for their disease (post-operativ setting)
by week 12 (or extended to week 15 if oral mucositis adapted RTOG/EORTC Grade ≥3 at week 12)
Germany: Federal Institute for Drugs and Medical Devices