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Hearing Disorders

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Ebselen

Anti-Inflammatory Agents, Non-Steroidal

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200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Arms: Low Dose

Other Names:

200 mg Ebselen

SPI-1005 Low Dose

Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

SPI-1005 Middle Dose

Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

SPI-1005 High Dose

Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Placebo

Eric Lynch, PhD

Tony S. Quang, M.D.

Tony S Quang, M.D.

Jonathan Kil, MD

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.

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

VA Puget Sound Health Care System

Sound Pharmaceuticals, Incorporated

Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose

2x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose

4x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose

8x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose

Matching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose

200 mg Ebselen oral capsules (SPI-1005), single dose

SPI-1005

0 mg Ebselen oral capsules (SPI-1000), single dose

James C. Kisicki, M.D.

A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.

Study to Evaluate the Safety and Pharmacokinetics of SPI-1005

A Phase 1, Double-blind, Placebo-controled, Randomized Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SPI-1005 (Ebselen)in Healthy Adult Subjects

The primary objective of this study was to evaluate the safety and tolerability of SPI-1005 (ebselen) in healthy subjects. Incidence and severity of Adverse Events were determined in all treatment and placebo groups.

Evaluate the single dose pharmacokinetic profile of SPI-1005 in healthy subjects including Tmax, Cmax, of the parent compound and major metabolites.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss	NCT01451853	Lung Cancer Head and Neck C... Hearing Loss Ototoxicity Tinnitus Neuropathy	SPI-1005 Low Do... SPI-1005 Middle... SPI-1005 High D... Placebo	19 Years - 80 Years	Sound Pharmaceuticals, Incorporated
Study to Evaluate the Safety and Pharmacokinetics of SPI-1005	NCT01452607	Hearing Loss Cancer	SPI-1005 Placebo	19 Years - 50 Years	Sound Pharmaceuticals, Incorporated

Spots Global Cancer Trial Database for ebselen

Every month we try and update this database with for ebselen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ebselen

Every month we try and update this database with for ebselen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ebselen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.