A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Inclusion Criteria:

• Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
• Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
• Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
• Must be able to read and understand informed consent
• Adequate birth control methods for the duration of the study

Exclusion Criteria:

• Current mucositis.
• Prior radiation to the head and neck.
• Chemotherapy treatment within the previous 12 months.
• Tumors of the lips, sinuses, salivary glands or nasopharynx.
• Unknown primary tumor.
• Stage 4c metastases.
• Evidence of significant hepatic, hematologic, or immunologic disease.
• Women who are pregnant or breast-feeding.