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

A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy

The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.

Inclusion Criteria:

• History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)
• Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg

Exclusion Criteria:

• Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins
• Metastatic disease (M1)
• Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years
• History of pancreatitis
• Prior radiotherapy to the site of disease
• Prior chemotherapy or requiring chemotherapy during treatment phase of study
• Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors