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

Phase 2

Terminated

• Conditions: Cisplatin Induced Hearing Loss
• Interventions: Drug: OTO-104

• Registration Number: NCT02997189
• Lead Sponsor: Otonomy, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-15
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-19
• Primary Completion: 2017-09-26
• Study Completion: 2017-09-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTO-104	OTO-104	One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy

Primary Outcome Measures

Name	Time	Method
Feasibility assessed via a questionnaire	Up to 18 weeks	Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen

Secondary Outcome Measures

Name	Time	Method
Local tolerability as assessed by otoscopic examinations	Up to 6 months
Hearing function in each ear according to SIOP-Boston Ototoxicity Scale	Up to 6 months
Safety as assessed by adverse events	Up to 6 months

Trial Locations

Locations (1)

Contact Otonomy call center for trial locations; 🇺🇸 San Diego, California, United States