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

Primary Purpose

Lung Cancer, Head and Neck Cancer, Hearing Loss

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SPI-1005 Low Dose

SPI-1005 Middle Dose

SPI-1005 High Dose

Placebo

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, Head and Neck Cancer, Hearing Loss, Ototoxicity, Tinnitus, Deafness, SPI-1005, Cisplatin, Carboplatin, Ebselen

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Puget Sound Health Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SPI-1005 Low Dose

SPI-1005 Middle Dose

SPI-1005 High Dose

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Reduction of hearing loss incidence and severity

Reduction of tinnitus incidence and severity.

Full Information

NCT ID

NCT01451853

First Posted

October 7, 2011

Last Updated

September 21, 2017

Sponsor

Sound Pharmaceuticals, Incorporated

Collaborators

VA Puget Sound Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT01451853

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 15, 2018 (Anticipated)

Primary Completion Date

June 26, 2019 (Anticipated)

Study Completion Date

September 23, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sound Pharmaceuticals, Incorporated

Collaborators

VA Puget Sound Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Lung Cancer, Head and Neck Cancer, Hearing Loss, Ototoxicity, Tinnitus, Deafness, SPI-1005, Cisplatin, Carboplatin, Ebselen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SPI-1005 Low Dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

SPI-1005 Middle Dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

SPI-1005 High Dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SPI-1005 Low Dose

Other Intervention Name(s)

200 mg Ebselen

Intervention Description

Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Arms: Low Dose Other Names: 200 mg Ebselen

Intervention Type

Drug

Intervention Name(s)

SPI-1005 Middle Dose

Other Intervention Name(s)

400 mg Ebselen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SPI-1005 High Dose

Other Intervention Name(s)

600 mg Ebselen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

0 mg Ebselen

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Reduction of hearing loss incidence and severity

Time Frame

From baseline through 1 month after last chemotherapy cycle

Title

Reduction of tinnitus incidence and severity.

Time Frame

From baseline through 1 month after last chemotherapy cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eric Lynch, PhD

Phone

(206) 634-2559

elynch@soundpharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Kil, MD

Organizational Affiliation

Sound Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

VA Puget Sound Health Care

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tony S. Quang, M.D.

Phone

206-768-5356

First Name & Middle Initial & Last Name & Degree

Tony S Quang, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

10569399

Citation

Rybak LP, Whitworth C, Somani S. Application of antioxidants and other agents to prevent cisplatin ototoxicity. Laryngoscope. 1999 Nov;109(11):1740-4. doi: 10.1097/00005537-199911000-00003.

Results Reference

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PubMed Identifier

10842591

Citation

Rybak LP, Somani S. Ototoxicity. Amelioration by protective agents. Ann N Y Acad Sci. 1999 Nov 28;884:143-51.

Results Reference

background

PubMed Identifier

15721563

Citation

Lynch ED, Gu R, Pierce C, Kil J. Reduction of acute cisplatin ototoxicity and nephrotoxicity in rats by oral administration of allopurinol and ebselen. Hear Res. 2005 Mar;201(1-2):81-9. doi: 10.1016/j.heares.2004.08.002.

Results Reference

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PubMed Identifier

15846123

Citation

Lynch ED, Gu R, Pierce C, Kil J. Combined oral delivery of ebselen and allopurinol reduces multiple cisplatin toxicities in rat breast and ovarian cancer models while enhancing anti-tumor activity. Anticancer Drugs. 2005 Jun;16(5):569-79. doi: 10.1097/00001813-200506000-00013.

Results Reference

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PubMed Identifier

17401008

Citation

Knight KR, Kraemer DF, Winter C, Neuwelt EA. Early changes in auditory function as a result of platinum chemotherapy: use of extended high-frequency audiometry and evoked distortion product otoacoustic emissions. J Clin Oncol. 2007 Apr 1;25(10):1190-5. doi: 10.1200/JCO.2006.07.9723.

Results Reference

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PubMed Identifier

18753950

Citation

Reavis KM, Phillips DS, Fausti SA, Gordon JS, Helt WJ, Wilmington D, Bratt GW, Konrad-Martin D. Factors affecting sensitivity of distortion-product otoacoustic emissions to ototoxic hearing loss. Ear Hear. 2008 Dec;29(6):875-93. doi: 10.1097/AUD.0b013e318181ad99.

Results Reference

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PubMed Identifier

19286452

Citation

Kim SJ, Park C, Han AL, Youn MJ, Lee JH, Kim Y, Kim ES, Kim HJ, Kim JK, Lee HK, Chung SY, So H, Park R. Ebselen attenuates cisplatin-induced ROS generation through Nrf2 activation in auditory cells. Hear Res. 2009 May;251(1-2):70-82. doi: 10.1016/j.heares.2009.03.003. Epub 2009 Mar 13.

Results Reference

background

Citation

Lynch E, Kil J. Development of Ebselen, a Glutathione Peroxidase Mimic, for the Prevention and Treatment of Noise-Induced Hearing Loss. Semin Hear 2009; 30(1): 047-055

Results Reference

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

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