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

NCT02997189 | Terminated Phase 2 DMC

• 1 other identifier: 104-201607
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cisplatin Induced Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Feasibility assessed via a questionnaire

  Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen

  Up to 18 weeks

Secondary Outcomes (3)

• 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

• Local tolerability as assessed by otoscopic examinations

  Up to 6 months

Study Arms (2)

OTO-104

ACTIVE COMPARATOR

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

Drug: OTO-104

Control

NO INTERVENTION

The ear not receiving OTO-104 will receive no treatment

Interventions

OTO-104 DRUG

12 mg dexamethasone administered intratympanically

OTO-104

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Otonomy, Inc.: lead

Study Sites (1)

Contact Otonomy call center for trial locations

San Diego, California, 92121, United States

Location

Related 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.

  PMID: 26789647 BACKGROUND

Study Officials

• Kathie Bishop, PhD

  Otonomy, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: November 15, 2016
• Primary Completion: September 26, 2017
• Study Completion: September 26, 2017
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)