Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2017-09-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Cisplatin Induced Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OTO-104

One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy

Group Type ACTIVE_COMPARATOR

OTO-104

Intervention Type DRUG

12 mg dexamethasone administered intratympanically

Control

The ear not receiving OTO-104 will receive no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OTO-104

12 mg dexamethasone administered intratympanically

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No