<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/NCT03041285</url>
  </required_header>
  <id_info>
    <org_study_id>NOX66 version 1</org_study_id>
    <nct_id>NCT03041285</nct_id>
  </id_info>
  <brief_title>Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer</brief_title>
  <official_title>Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal North Shore Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal North Shore Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in&#xD;
      combination with palliative radiotherapy for metastatic prostate cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Who is it for? Patient may be eligible for this study if they have late stage metastatic&#xD;
      prostate cancer which is castrate resistant and have metastatic lesions that are suitable for&#xD;
      radiotherapy.&#xD;
&#xD;
      Study details There are two groups of patients in this study and no randomisation. The two&#xD;
      groups will have two different doses of idronoxil (NOX66), representing a 2-step dose&#xD;
      escalation. Both groups receive the same standard radiotherapy dose.&#xD;
&#xD;
      Group 1 will receive the lower dose (400 mg) of idronoxil suppository daily and Group 2 800&#xD;
      mg daily.&#xD;
&#xD;
      Recruitment into Group 2 will only commence once all Group 1 patients have completed the&#xD;
      13-day treatment course of idronoxil suppository without excessive unexpected toxicity. The&#xD;
      total treatment duration will be 13-15 days for both groups depends on whether radiotherapy&#xD;
      is given on consecutive days or over the weekend.&#xD;
&#xD;
      Day 0: commence idronoxil (NOX66) Days 1-5: 1 or 2 lesions will receive 20 Gy (radiotherapy&#xD;
      dose unit) radiotherapy in 5 daily fractionated doses and continue daily NOX66 Day 6-12:&#xD;
      Continue NOX66 (the duration of NOX66 will be 13-15 days depends on whether radiotherapy is&#xD;
      given on consecutive days or over the weekend).&#xD;
&#xD;
      Both groups will have prostate-specific membrane antigen positron emission tomography&#xD;
      (PSMA-PET) scans before starting treatment and three months after the last fraction of&#xD;
      radiotherapy to assess treatment response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    have difficulty finding eligible participants&#xD;
  </why_stopped>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Actual">September 17, 2019</completion_date>
  <primary_completion_date type="Actual">September 17, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Group 1 (6 participants) will receive 400mg of Idronoxil (NOX66) daily in the form of one suppository. Group 2 (6 participants) will receive 800mg of Idronoxil daily (two suppositories). Group 2 will only commence once all group 1 participants have completed their treatment course and have experienced no toxicity greater than grade 2 according CTCAE version 4.03 for adverse events assessment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>There is no masking.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>safety of Idronoxil dose escalation</measure>
    <time_frame>From start of NOX66 with stereotactic radiotherapy up to three months post treatment.</time_frame>
    <description>Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evidence of clinical tumour response</measure>
    <time_frame>3 months post treatment</time_frame>
    <description>PSMA-PET CT will be done before and 3 months after treatment. The change in SUV in PSMA PET will be used to assess tumour metabolic response.&#xD;
Pre and post treatment tumour size on CT will be measured and RECIST criteria will be used to measure tumour response.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Metastatic Castrate- Resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Group 1 NOX66 400mg and SBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 patients will receive 400mg of Idronoxil (NOX66) suppository (1 suppository) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 NOX66 800mg and SBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 patients will receive 800mg of Idronoxil (NOX66) suppository (2 suppositories) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>idronoxil (NOX66) suppository</intervention_name>
    <description>Patients in Group 1 will be given 400mg of Idronoxil suppository (NOX66) (1 suppository) daily from Day 0(1 day before radiotherapy) until 7 days after radiotherapy. Group 2 will be given Idronoxil (NOX66) 800mg (2 suppositories) daily from Day 0 until 7 days after radiotherapy.&#xD;
All patients will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 fractions.&#xD;
Radiotherapy session will involve irradiation of 1-2 lesions.&#xD;
.</description>
    <arm_group_label>Group 1 NOX66 400mg and SBRT</arm_group_label>
    <arm_group_label>Group 2 NOX66 800mg and SBRT</arm_group_label>
    <other_name>NOX66</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy</intervention_name>
    <description>All patients (Group 1 and Group 2) will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 daily fractions on consecutive days. Radiotherapy session (week 1) will involve irradiation to 1-2 lesions.</description>
    <arm_group_label>Group 1 NOX66 400mg and SBRT</arm_group_label>
    <arm_group_label>Group 2 NOX66 800mg and SBRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed metastatic prostate cancer that is castrate-resistant.&#xD;
&#xD;
          -  2-3 lesions suitable for radiotherapy.&#xD;
&#xD;
          -  ECOG Performance status 0-2.&#xD;
&#xD;
               -  Adequate bone marrow, hepatic and renal function&#xD;
&#xD;
               -  At least 4 weeks must have elapsed prior to commencement of idronoxil treatment&#xD;
                  since prior chemotherapy, investigational drug or biologic therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemotherapy regimens with delayed toxicity within the last 4 weeks.&#xD;
&#xD;
          -  Any situation where the use of suppository therapy is contra-indicated or&#xD;
             impractical(eg. chronic diarrhoea, colostomy, ulcerative colitis).&#xD;
&#xD;
          -  No concurrent systemic chemotherapy or biologic therapy is allowed.&#xD;
&#xD;
          -  Psychiatric disorder or social or geographic situation that would preclude study&#xD;
             participation.&#xD;
&#xD;
          -  Patient unable to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Eade</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northern Sydney Local Health District</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal North Shore Hospital</investigator_affiliation>
    <investigator_full_name>Professor Thomas Eade</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03041285
org study id: NOX66 version 1
nct id: NCT03041285
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in
      combination with palliative radiotherapy for metastatic prostate cancer
Who is it for? Patient may be eligible for this study if they have late stage metastatic
      prostate cancer which is castrate resistant and have metastatic lesions that are suitable for
      radiotherapy.

      Study details There are two groups of patients in this study and no randomisation. The two
      groups will have two different doses of idronoxil (NOX66), representing a 2-step dose
      escalation. Both groups receive the same standard radiotherapy dose.

      Group 1 will receive the lower dose (400 mg) of idronoxil suppository daily and Group 2 800
      mg daily.

      Recruitment into Group 2 will only commence once all Group 1 patients have completed the
      13-day treatment course of idronoxil suppository without excessive unexpected toxicity. The
      total treatment duration will be 13-15 days for both groups depends on whether radiotherapy
      is given on consecutive days or over the weekend.

      Day 0: commence idronoxil (NOX66) Days 1-5: 1 or 2 lesions will receive 20 Gy (radiotherapy
      dose unit) radiotherapy in 5 daily fractionated doses and continue daily NOX66 Day 6-12:
      Continue NOX66 (the duration of NOX66 will be 13-15 days depends on whether radiotherapy is
      given on consecutive days or over the weekend).

      Both groups will have prostate-specific membrane antigen positron emission tomography
      (PSMA-PET) scans before starting treatment and three months after the last fraction of
      radiotherapy to assess treatment response.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Group 1 (6 participants) will receive 400mg of Idronoxil (NOX66) daily in the form of one suppository. Group 2 (6 participants) will receive 800mg of Idronoxil daily (two suppositories). Group 2 will only commence once all group 1 participants have completed their treatment course and have experienced no toxicity greater than grade 2 according CTCAE version 4.03 for adverse events assessment.
primary purpose: Treatment
masking: None (Open Label)
masking description: There is no masking.
measure: safety of Idronoxil dose escalation
time frame: From start of NOX66 with stereotactic radiotherapy up to three months post treatment.
description: Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3
measure: evidence of clinical tumour response
time frame: 3 months post treatment
description: PSMA-PET CT will be done before and 3 months after treatment. The change in SUV in PSMA PET will be used to assess tumour metabolic response.
Pre and post treatment tumour size on CT will be measured and RECIST criteria will be used to measure tumour response.
arm group label: Group 1 NOX66 400mg and SBRT
arm group type: Experimental
description: Group 1 patients will receive 400mg of Idronoxil (NOX66) suppository (1 suppository) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.
arm group label: Group 2 NOX66 800mg and SBRT
arm group type: Experimental
description: Group 2 patients will receive 800mg of Idronoxil (NOX66) suppository (2 suppositories) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.
intervention type: Drug
intervention name: idronoxil (NOX66) suppository
description: Patients in Group 1 will be given 400mg of Idronoxil suppository (NOX66) (1 suppository) daily from Day 0(1 day before radiotherapy) until 7 days after radiotherapy. Group 2 will be given Idronoxil (NOX66) 800mg (2 suppositories) daily from Day 0 until 7 days after radiotherapy.
All patients will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 fractions.
Radiotherapy session will involve irradiation of 1-2 lesions.
.
arm group label: Group 1 NOX66 400mg and SBRT
arm group label: Group 2 NOX66 800mg and SBRT
other name: NOX66
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy
description: All patients (Group 1 and Group 2) will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 daily fractions on consecutive days. Radiotherapy session (week 1) will involve irradiation to 1-2 lesions.
arm group label: Group 1 NOX66 400mg and SBRT
arm group label: Group 2 NOX66 800mg and SBRT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Eade
role: Principal Investigator
affiliation: Northern Sydney Local Health District
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Royal North Shore Hospital
investigator full name: Professor Thomas Eade
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
sharing ipd: No