<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02997189</url>
  </required_header>
  <id_info>
    <org_study_id>104-201607</org_study_id>
    <nct_id>NCT02997189</nct_id>
  </id_info>
  <brief_title>Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otonomy, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otonomy, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of&#xD;
      OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from&#xD;
      cisplatin chemotherapy regimens in the treatment of cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Negative Efficacy Results from the recently completed Phase 3 study 104-201506&#xD;
  </why_stopped>
  <start_date type="Actual">November 15, 2016</start_date>
  <completion_date type="Actual">September 26, 2017</completion_date>
  <primary_completion_date type="Actual">September 26, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility assessed via a questionnaire</measure>
    <time_frame>Up to 18 weeks</time_frame>
    <description>Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hearing function in each ear according to SIOP-Boston Ototoxicity Scale</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety as assessed by adverse events</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local tolerability as assessed by otoscopic examinations</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cisplatin Induced Hearing Loss</condition>
  <arm_group>
    <arm_group_label>OTO-104</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The ear not receiving OTO-104 will receive no treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OTO-104</intervention_name>
    <description>12 mg dexamethasone administered intratympanically</description>
    <arm_group_label>OTO-104</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is aged 6 months to 21 years inclusive.&#xD;
&#xD;
          -  Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial&#xD;
             germ cell tumors and has not been previously treated with cisplatin or carboplatin.&#xD;
&#xD;
          -  Subject is scheduled to receive a chemotherapy regimen that includes a cumulative&#xD;
             cisplatin dose of ≥ 200 mg/m2.&#xD;
&#xD;
          -  Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000&#xD;
             Hz, in both ears and does not have a history of sensorineural hearing loss.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has middle ear effusion upon clinical examination.&#xD;
&#xD;
          -  Subject has a history of central nervous system radiotherapy that encompasses all or&#xD;
             part of the cochlea or will receive such radiation therapy during the course of the&#xD;
             study.&#xD;
&#xD;
          -  Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.&#xD;
&#xD;
          -  Subject is currently participating on a separate otoprotection clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathie Bishop, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Otonomy, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Contact Otonomy call center for trial locations</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>26789647</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 20, 2022</submitted>
    <returned>November 14, 2022</returned>
    <submitted>November 14, 2022</submitted>
    <returned>December 9, 2022</returned>
    <submitted>December 29, 2022</submitted>
    <returned>January 24, 2023</returned>
    <submitted>June 15, 2023</submitted>
    <returned>July 7, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02997189
org study id: 104-201607
nct id: NCT02997189
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Feasibility assessed via a questionnaire
time frame: Up to 18 weeks
description: Feasibility to assess incorporating OTO-104 with a cisplatin-based therapy regimen
measure: Hearing function in each ear according to SIOP-Boston Ototoxicity Scale
time frame: Up to 6 months
measure: Safety as assessed by adverse events
time frame: Up to 6 months
measure: Local tolerability as assessed by otoscopic examinations
time frame: Up to 6 months
arm group label: OTO-104
arm group type: Active Comparator
description: One of the subject's ears will receive up to three administrations of study drug prior to cisplatin-based therapy
arm group label: Control
arm group type: No Intervention
description: The ear not receiving OTO-104 will receive no treatment
intervention type: Drug
intervention name: OTO-104
description: 12 mg dexamethasone administered intratympanically
arm group label: OTO-104
criteria: 
gender: All
minimum age: 6 Months
maximum age: 21 Years
healthy volunteers: No
last name: Kathie Bishop, PhD
role: Study Chair
affiliation: Otonomy, Inc.
facility: 
country: United States
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.
PMID: 26789647
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
submitted: October 20, 2022
returned: November 14, 2022
submitted: November 14, 2022
returned: December 9, 2022
submitted: December 29, 2022
returned: January 24, 2023
submitted: June 15, 2023
returned: July 7, 2023