Lung Cancer Clinical Trial
Official title:
Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss
Chemotherapy treatment with platinum based agents is well noted to cause 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, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.
Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin,
carboplatin) are well noted and studied for their ability to cause ototoxicity which includes
hearing loss, tinnitus, vertigo, or dizziness. 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, surrounding each cycle of platinum chemotherapy for head and neck or non-small
cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and
tinnitus.
SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer 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.
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