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

Not Recruiting

Trial ID: NCT02997189


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.

Official Title

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

Stanford Investigator(s)

Kay W. Chang, MD
Kay W. Chang, MD

Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics


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

   - Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.

   - Subject is currently participating on a separate otoprotection clinical study.


drug: OTO-104

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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