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

Otonomy

Status and phase

Terminated

Phase 2

Conditions

Cisplatin Induced Hearing Loss

Treatments

Drug: OTO-104

Study type

Interventional

Funder types

Industry

Identifiers

NCT02997189

104-201607

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

6 months to 21 years old

Volunteers

No 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.