Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
Stopped early · Phase 2
Conditions studied: Cisplatin Induced Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT02997189
- Run by
- Otonomy, Inc.
- People needed
- 12
- Starts
- 2016-11-15
- Expected to finish
- 2017-09-26
- Last updated by the study team
- 2020-09-16
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Contact Otonomy call center for trial locations — San Diego, California, United States
Full record on ClinicalTrials.gov
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