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

Cisplatin Induced Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02997189
• Other study ID #: 104-201607
• Status: Terminated
• Phase: Phase 2
• Start date: November 15, 2016
• Est. completion date: September 26, 2017

Study information

• Verified date: September 2020
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 26, 2017
• Est. primary completion date: September 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cisplatin Induced Hearing Loss
• Deafness
• Hearing Loss

Intervention

Drug:
• OTO-104
12 mg dexamethasone administered intratympanically

Locations

Country	Name	City	State
United States	Contact Otonomy call center for trial locations	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fernandez R, Harrop-Jones A, Wang X, Dellamary L, LeBel C, Piu F. The Sustained-Exposure Dexamethasone Formulation OTO-104 Offers Effective Protection against Cisplatin-Induced Hearing Loss. Audiol Neurootol. 2016;21(1):22-9. doi: 10.1159/000441833. Epub 2016 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility assessed via a questionnaire	Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen	Up to 18 weeks
Secondary	Hearing function in each ear according to SIOP-Boston Ototoxicity Scale		Up to 6 months
Secondary	Safety as assessed by adverse events		Up to 6 months
Secondary	Local tolerability as assessed by otoscopic examinations		Up to 6 months