SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
NCT ID: NCT01451853
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2018-01-15
2019-09-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SPI-1005 Low Dose
200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
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
SPI-1005 Middle Dose
400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
SPI-1005 Middle Dose
Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
SPI-1005 High Dose
600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
SPI-1005 High Dose
Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Placebo
0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Placebo
Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Interventions
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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
SPI-1005 Middle Dose
Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
SPI-1005 High Dose
Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Placebo
Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
80 Years
ALL
No
Sponsors
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VA Puget Sound Health Care System
FED
Sound Pharmaceuticals, Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Kil, MD
Role: STUDY_DIRECTOR
Sound Pharmaceuticals, Inc.
Locations
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VA Puget Sound Health Care
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Tony S. Quang, M.D.
Role: primary
References
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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.
Rybak LP, Somani S. Ototoxicity. Amelioration by protective agents. Ann N Y Acad Sci. 1999 Nov 28;884:143-51.
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.
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.
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.
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.
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.
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
Other Identifiers
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SPI-3005-201
Identifier Type: -
Identifier Source: org_study_id