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
Sponsored by
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
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
Active Comparator
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
No
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
No
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
Email
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
background
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
background
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
background
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
background
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
background
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
background
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SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
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