Clinical trial · Interventional
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cisplatin Induced Hearing Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OTO-104 | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- OTO-104
- description
- One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy
- interventionNames
- Drug: OTO-104
- type
- NO_INTERVENTION
- label
- Control
- description
- The ear not receiving OTO-104 will receive no treatment
Primary outcomes (1)
- measure
- Feasibility assessed via a questionnaire
- timeFrame
- Up to 18 weeks
- description
- Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- BACKGROUNDFernandez 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. PMID 26789647