A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of ALD518 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concomitant Chemotherapy and Radiotherapy
ID Number 12-0276Principal Investigator(s)
MARCELO R BONOMI
Department(s) or Division(s)
Hematology and Medical Oncology
You are being asked to participate in this research study because you may develop mouth sores or oral mucositis as a result of the chemotherapy and radiation you are receiving for your Head and Neck cancer. The purpose of this study is to find how good or bad (safety) and how well (effectiveness) the experimental drug ALD518 work on you and your mouth sores. In this study, you receive ALD518 160 mg, ALD518 320 mg, or an infusion of saline, which will not contain any ALD518.
An experimental drug is one that has not been approved for general use by the U.S. Food and Drug Administration (FDA). ALD518 (the “study drug”) can only be used in research studies. ALD518 is a protein that binds interleukin-6 (IL-6). IL-6 is a naturally occurring substance in your body; elevated levels of IL-6 have been associated with numerous diseases including mouth sores.
Recruiting Patients: Yes