Lung CancerPhase 2NCT01451853
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
A Phase 2 study testing SPI-1005 Low Dose, SPI-1005 Middle Dose and SPI-1005 High Dose in people with Lung Cancer and Head and Neck Cancer, run by Sound Pharmaceuticals, Incorporated at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Lung Cancer, Head and Neck Cancer, Hearing Loss
- What is being tested?
- SPI-1005 Low Dose, SPI-1005 Middle Dose and SPI-1005 High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care
Seattle, Washington, 98108
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Head and Neck Cancer, Hearing Loss, Ototoxicity, Tinnitus, Neuropathy
- Being tested
- SPI-1005 Low Dose, SPI-1005 Middle Dose, SPI-1005 High Dose, Placebo
- Keywords
- Lung Cancer, Head and Neck Cancer, Hearing Loss, Ototoxicity, Tinnitus, Deafness, SPI-1005, Cisplatin, Carboplatin, Ebselen
- Medical subject headings
- Lung Neoplasms, Head and Neck Neoplasms, Hearing Loss, Ototoxicity, Tinnitus, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-1005 Low DoseDrug
Also called 200 mg Ebselen
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 DoseDrug
Also called 400 mg Ebselen
Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
SPI-1005 High DoseDrug
Also called 600 mg Ebselen
Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
PlaceboDrug
Also called 0 mg Ebselen
Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| SPI-1005 Low Dose | Active comparator | 200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy Receives: Drug: SPI-1005 Low Dose |
| SPI-1005 Middle Dose | Active comparator | 400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy Receives: Drug: SPI-1005 Middle Dose |
| SPI-1005 High Dose | Active comparator | 600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy Receives: Drug: SPI-1005 High Dose |
| Placebo | Placebo comparator | 0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 12 months
Secondary outcomes (2)
Reduction of hearing loss incidence and severity
Measured: From baseline through 1 month after last chemotherapy cycle
Reduction of tinnitus incidence and severity.
Measured: From baseline through 1 month after last chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJun 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Study did not start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Puget Sound Health Care System
- Responsible party
- Sponsor
- Investigators
- Jonathan Kil, MD, Study director, Sound Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451853
- Sponsor's protocol ID
- SPI-3005-201
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2011
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 10569399Rybak LP, Somani S. Ototoxicity. Amelioration by protective agents. Ann N Y Acad Sci. 1999 Nov 28;884:143-51.
PubMed 10842591Lynch 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.
PubMed 15721563Lynch 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.
PubMed 15846123Knight 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.
PubMed 17401008Reavis 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.
PubMed 18753950Kim 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.
PubMed 19286452Lynch 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss
- ClinicalTrials.gov ID
- NCT01451853
- Acronym / sponsor ID
- SPI-3005-201
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- VA Puget Sound Health Care System
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPI-1005 Low Dose | Active comparator | Drug: SPI-1005 Low Dose200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy |
| SPI-1005 Middle Dose | Active comparator | Drug: SPI-1005 Middle Dose400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy |
| SPI-1005 High Dose | Active comparator | Drug: SPI-1005 High Dose600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy |
| Placebo | Placebo comparator | Drug: Placebo0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPI-1005 Low DoseAlso: 200 mg EbselenOral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Arms: Low Dose Other Names: 200 mg Ebselen | Drug | SPI-1005 Low Dose |
| SPI-1005 Middle DoseAlso: 400 mg EbselenOral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy | Drug | SPI-1005 Middle Dose |
| SPI-1005 High DoseAlso: 600 mg EbselenOral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy | Drug | SPI-1005 High Dose |
| PlaceboAlso: 0 mg EbselenOral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: 12 months
2 secondary outcomes
Reduction of hearing loss incidence and severity
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 10569399Rybak 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.
- Background: PubMed 10842591Rybak LP, Somani S. Ototoxicity. Amelioration by protective agents. Ann N Y Acad Sci. 1999 Nov 28;884:143-51.
- Background: PubMed 15721563Lynch 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.
- Background: PubMed 15846123Lynch 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.
- Background: PubMed 17401008Knight 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.
- Background: PubMed 18753950Reavis 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.
- Background: PubMed 19286452Kim 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.
- BackgroundLynch 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Kil, MD study director
Sound Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPI-1005 Low Dose, SPI-1005 Middle Dose and SPI-1005 High Dose in people with Lung Cancer and Head and Neck Cancer, run by Sound Pharmaceuticals, Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01451853, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.