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

September 14, 2020 updated by: Otonomy, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Contact Otonomy call center for trial locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: OTO-104
One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy
Drug: OTO-104
12 mg dexamethasone administered intratympanically
NO_INTERVENTION: Control
The ear not receiving OTO-104 will receive no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility assessed via a questionnaire
Time Frame: Up to 18 weeks
Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen
Up to 18 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otonomy, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2016

Primary Completion (ACTUAL)

September 26, 2017

Study Completion (ACTUAL)

September 26, 2017

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-201607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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