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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02997189

Enrollment

Registered

2016-12-19

Start date

2016-11-15

Completion date

2017-09-26

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cisplatin Induced Hearing Loss

Brief 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.

Interventions

DRUGOTO-104

12 mg dexamethasone administered intratympanically

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 21 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility assessed via a questionnaire	Up to 18 weeks	Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen

Secondary

Measure	Time frame
Hearing function in each ear according to SIOP-Boston Ototoxicity Scale	Up to 6 months
Safety as assessed by adverse events	Up to 6 months
Local tolerability as assessed by otoscopic examinations	Up to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026