Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 9/16/2017 |
| Start Date: | November 2016 |
| End Date: | September 2017 |
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
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.
OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from
cisplatin chemotherapy regimens in the treatment of cancer.
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.
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