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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02997189
Recruitment Status : Terminated (Negative Efficacy Results from the recently completed Phase 3 study 104-201506)
First Posted : December 19, 2016
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cisplatin Induced Hearing Loss Drug: OTO-104 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : September 26, 2017
Actual Study Completion Date : September 26, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Feasibility assessed via a questionnaire [ Time Frame: Up to 18 weeks ]
    Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen


Secondary Outcome Measures :
  1. Hearing function in each ear according to SIOP-Boston Ototoxicity Scale [ Time Frame: Up to 6 months ]
  2. Safety as assessed by adverse events [ Time Frame: Up to 6 months ]
  3. Local tolerability as assessed by otoscopic examinations [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997189


Locations
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United States, California
Contact Otonomy call center for trial locations
San Diego, California, United States, 92121
Sponsors and Collaborators
Otonomy, Inc.
Investigators
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Study Chair: Kathie Bishop, PhD Otonomy, Inc.
Publications:
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02997189    
Other Study ID Numbers: 104-201607
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases