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

NCT01451853 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-09-25

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • VA Puget Sound Health Care System

    collaborator FED

  • Sound Pharmaceuticals, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jonathan Kil, MD · Sound Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2019-06-26
Completion
2019-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01451853 on ClinicalTrials.gov