Cisplatin Induced Hearing LossPhase 2NCT02997189
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
A Phase 2 study testing OTO-104 in people with Cisplatin Induced Hearing Loss, run by Otonomy, Inc. at 1 site in United States.
Trial summary
This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Cisplatin Induced Hearing Loss
- What is being tested?
- OTO-104
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2016to 26 Sep 2017
- 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 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject is aged 6 months to 21 years inclusive.
- Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin.
- Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ≥ 200 mg/m2.
- Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000 Hz, in both ears and does not have a history of sensorineural hearing loss.
Who cannot join
- Subject has middle ear effusion upon clinical examination.
- Subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study.
- Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.
- Subject is currently participating on a separate otoprotection clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Otonomy call center for trial locations
San Diego, California, 92121
About this study
Official title: A Multicenter, Randomized, Phase 2 Study to Assess the Feasibility, Safety and Efficacy of OTO-104 Given by Intratympanic Administration in Subjects at Risk for Ototoxicity From Cisplatin Chemotherapy Regimens in the Treatment of Cancer
This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.
- Conditions
- Cisplatin Induced Hearing Loss
- Being tested
- OTO-104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTO-104Drug
12 mg dexamethasone administered intratympanically
| Study group | Role | What they receive |
|---|---|---|
| OTO-104 | Active comparator | One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy Receives: Drug: OTO-104 |
| Control | No intervention | The ear not receiving OTO-104 will receive no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed via a questionnaire
Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen
Measured: Up to 18 weeks
Secondary outcomes (3)
Hearing function in each ear according to SIOP-Boston Ototoxicity Scale
Measured: Up to 6 months
Safety as assessed by adverse events
Measured: Up to 6 months
Local tolerability as assessed by otoscopic examinations
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start15 Nov 2016
- Primary completion26 Sep 2017
- Study completion26 Sep 2017
Why it stopped: Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cisplatin Induced Hearing LossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathie Bishop, PhD, Study chair, Otonomy, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997189
- Sponsor's protocol ID
- 104-201607
- Status last verified
- Sep 2020
- First submitted
- 15 Dec 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez R, Harrop-Jones A, Wang X, Dellamary L, LeBel C, Piu F. The Sustained-Exposure Dexamethasone Formulation OTO-104 Offers Effective Protection against Cisplatin-Induced Hearing Loss. Audiol Neurootol. 2016;21(1):22-9. doi: 10.1159/000441833. Epub 2016 Jan 21.
PubMed 26789647Freyer DR, Ohlsen TJD, Don D, Orgel E, Hayashi RJ, Lieu JE, Foster JH, Sitton MS, Geller JI, Choo DI, Rangaswami A, Chang KW, Greffe B, Chan K, Lee A, Grunstein E, O'Neill AF, Rahbar R, Anderson JJ. Feasibility and Safety of Intratympanic Administration of Sustained-Exposure Dexamethasone Thermosensitive Gel (OTO-104) for Prevention of Cisplatin-Induced Hearing Loss in Children: A Multisite Phase 2 Randomized Clinical Trial. Pediatr Blood Cancer. 2025 Jun;72(6):e31680. doi: 10.1002/pbc.31680. Epub 2025 Mar 24.
PubMed 40128126
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Phase 2 Study to Assess the Feasibility, Safety and Efficacy of OTO-104 Given by Intratympanic Administration in Subjects at Risk for Ototoxicity From Cisplatin Chemotherapy Regimens in the Treatment of Cancer
- ClinicalTrials.gov ID
- NCT02997189
- Acronym / sponsor ID
- 104-201607
- Conditions
- Cisplatin Induced Hearing Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Negative Efficacy Results from the recently completed Phase 3 study 104-201506
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 19 Dec 2016 (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.
This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTO-104 | Active comparator | Drug: OTO-104One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy |
| Control | No intervention | –The ear not receiving OTO-104 will receive no treatment |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subject is aged 6 months to 21 years inclusive.
- Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin.
- Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ≥ 200 mg/m2.
- Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000 Hz, in both ears and does not have a history of sensorineural hearing loss.
Key exclusion criteria (4 listed)
- Subject has middle ear effusion upon clinical examination.
- Subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study.
- Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.
- Subject is currently participating on a separate otoprotection clinical study.
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 |
|---|---|---|
| OTO-10412 mg dexamethasone administered intratympanically | Drug | OTO-104 |
Primary outcome
Feasibility assessed via a questionnaire
Time frame: Up to 18 weeks
Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen
3 secondary outcomes
Hearing function in each ear according to SIOP-Boston Ototoxicity Scale
Time frame: Up to 6 months
Safety as assessed by adverse events
Time frame: Up to 6 months
Local tolerability as assessed by otoscopic examinations
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Negative Efficacy Results from the recently completed Phase 3 study 104-201506). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 26789647Fernandez R, Harrop-Jones A, Wang X, Dellamary L, LeBel C, Piu F. The Sustained-Exposure Dexamethasone Formulation OTO-104 Offers Effective Protection against Cisplatin-Induced Hearing Loss. Audiol Neurootol. 2016;21(1):22-9. doi: 10.1159/000441833. Epub 2016 Jan 21.
- Derived from this study: PubMed 40128126Freyer DR, Ohlsen TJD, Don D, Orgel E, Hayashi RJ, Lieu JE, Foster JH, Sitton MS, Geller JI, Choo DI, Rangaswami A, Chang KW, Greffe B, Chan K, Lee A, Grunstein E, O'Neill AF, Rahbar R, Anderson JJ. Feasibility and Safety of Intratympanic Administration of Sustained-Exposure Dexamethasone Thermosensitive Gel (OTO-104) for Prevention of Cisplatin-Induced Hearing Loss in Children: A Multisite Phase 2 Randomized Clinical Trial. Pediatr Blood Cancer. 2025 Jun;72(6):e31680. doi: 10.1002/pbc.31680. Epub 2025 Mar 24.
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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.
Kathie Bishop, PhD study chair
Otonomy, 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 OTO-104 in people with Cisplatin Induced Hearing Loss, run by Otonomy, Inc. 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 Sep 2020. 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. 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 stopped early (reason given: Negative Efficacy Results from the recently completed Phase 3 study 104-201506). Results are not available in the source record.
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?
Feasibility assessed via a questionnaire (time frame: Up to 18 weeks). 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 NCT02997189, which also lists 2 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 16 Sep 2020.