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

September 21, 2017 updated by: Sound Pharmaceuticals, Incorporated

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care
        • Contact:
          • Tony S. Quang, M.D.
          • Phone Number: 206-768-5356
        • Principal Investigator:
          • Tony S Quang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult male and female subjects, 19-80 years of age;
  • Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer
  • Voluntarily consent to participate in the study
  • Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
  • IUD in place for at least 3 months prior to study;
  • Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
  • Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
  • Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
  • Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).

Exclusion Criteria:

  • Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
  • Presence of alcoholism or drug abuse
  • Participation in another investigational drug or device clinical trial within 30 days prior to the study
  • Female subjects who are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SPI-1005 Low Dose
200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
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

Other Names:
  • 200 mg Ebselen
Active Comparator: SPI-1005 Middle Dose
400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: SPI-1005 Middle Dose
Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Names:
  • 400 mg Ebselen
Active Comparator: SPI-1005 High Dose
600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: SPI-1005 High Dose
Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Names:
  • 600 mg Ebselen
Placebo Comparator: Placebo
0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: Placebo
Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Names:
  • 0 mg Ebselen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of hearing loss incidence and severity
Time Frame: From baseline through 1 month after last chemotherapy cycle
From baseline through 1 month after last chemotherapy cycle
Reduction of tinnitus incidence and severity.
Time Frame: From baseline through 1 month after last chemotherapy cycle
From baseline through 1 month after last chemotherapy cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sound Pharmaceuticals, Incorporated

Collaborators

VA Puget Sound Health Care System

Investigators

  • Study Director: Jonathan Kil, MD, Sound Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2018

Primary Completion (Anticipated)

June 26, 2019

Study Completion (Anticipated)

September 23, 2019

Study Registration Dates

First Submitted

October 7, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-3005-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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