Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss (NCT02997189) | Clinical Trial Compass
TerminatedPhase 2
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
Stopped: Negative Efficacy Results from the recently completed Phase 3 study 104-201506
United States12 participantsStarted 2016-11-15
Plain-language 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.
Who can participate
Age range6 Months – 21 Years
SexALL
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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.