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

• Status: Terminated
• Trial end date: 2017-09-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otonomy, Inc.
• Treatments: Cisplatin

Criteria

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.