Chemotherapy treatment with the platinum containing chemotherapies (cisplatin, carboplatin) are well noted and studied for their ability to cause a side effect of hearing loss, also termed ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, during each cycle of cisplatin chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss.
SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.
Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)