Back to resultsStudy of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
Primary Purpose
Cisplatin Induced Hearing Loss
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTO-104
Sponsored by
About this trial
This is an interventional prevention trial for Cisplatin Induced Hearing Loss
Eligibility Criteria
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.
Sites / Locations
- Contact Otonomy call center for trial locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
OTO-104
Control
Arm Description
One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy
The ear not receiving OTO-104 will receive no treatment
Outcomes
Primary Outcome Measures
Feasibility assessed via a questionnaire
Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen
Secondary Outcome Measures
Hearing function in each ear according to SIOP-Boston Ototoxicity Scale
Safety as assessed by adverse events
Local tolerability as assessed by otoscopic examinations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02997189
Brief Title
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
September 26, 2017 (Actual)
Study Completion Date
September 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cisplatin Induced Hearing Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-104
Arm Type
Active Comparator
Arm Description
One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
The ear not receiving OTO-104 will receive no treatment
Intervention Type
Drug
Intervention Name(s)
OTO-104
Intervention Description
12 mg dexamethasone administered intratympanically
Primary Outcome Measure Information:
Title
Feasibility assessed via a questionnaire
Description
Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen
Time Frame
Up to 18 weeks
Secondary Outcome Measure Information:
Title
Hearing function in each ear according to SIOP-Boston Ototoxicity Scale
Time Frame
Up to 6 months
Title
Safety as assessed by adverse events
Time Frame
Up to 6 months
Title
Local tolerability as assessed by otoscopic examinations
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathie Bishop, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Contact Otonomy call center for trial locations
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26789647
Citation
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.
Results Reference
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Learn more about this trial
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
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