NCT01451853

SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss

Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sound Pharmaceuticals, Incorporated · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer
• Head and Neck Cancer
• Hearing Loss
• Ototoxicity
• Tinnitus
• Neuropathy

Interventions

Type	Name	Description
DRUG	SPI-1005 Low Dose	Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Arms: Low Dose Other Names: 200 mg Ebselen
DRUG	SPI-1005 Middle Dose	Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
DRUG	SPI-1005 High Dose	Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
DRUG	Placebo	Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Timeline

• Start date: 2018-01-15
• Primary completion: 2019-06-26
• Completion: 2019-09-23
• First posted: 2011-10-14
• Last updated: 2017-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study