A Pivotal, Double-blind, Randomized, Placebo-controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

Purpose

To test the safety & efficacy of SGX942 in any resulting oral mucositis in patients with squamous cell carcinoma of the head and neck who will also receive treatment with chemotherapy and radiation therapy

Criteria

Males or females 18 years of age or older  

Diagnosed with squamous cell carcinoma of the oral cavity or oropharynx that has been evaluated for human papillomavirus (HPV)

Scheduled to receive Cisplatin chemotherapy

Scheduled to receive radiation therapy between 55-72 Gy

You Cannot:            

Have current mucositis

Be scheduled to receive Erbitux (Cetuximab)

Have prior radiation to the head and neck

Have chemotherapy treatment within the previous 12 months

Have tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx

Have evidence of immediate life-threatening disease or a life expectancy of less than 3 months.

Details

The total study participation is up to 12 weeks not including the 12-month follow-up period.

Patients will receive an infusion of SGX942 or placebo every 3-4 days for a maximum of 24 doses within a 12 week period.

Follow-up visits will be completed at 3 weeks, 4 weeks, 5 weeks, 6 weeks, 12 weeks, & 12 months after the completion of chemoradiation therapy.

Follow-up contacts will also be completed each month between the 6 week & 12 month visits either by phone or clinic visit.



Interested in more information on this clinical research study?

Contact WK Cancer Center Clinical Research Department at 318-212-8671

Interested in more information? Contact Us:

Radiation Oncology Services

IRB: Willis-Knighton
IRB Number: 17.0008
Trial Type: NA
Sponsor: Soligenix