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WITHDRAWN
NCT01451853
PHASE2

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

Sponsor: Sound Pharmaceuticals, Incorporated

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2026-06

Completion Date

2026-06

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

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

Locations (1)

VA Puget Sound Health Care

Seattle, Washington, United States