<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/NCT03307629</url>
  </required_header>
  <id_info>
    <org_study_id>NOX66-002A</org_study_id>
    <nct_id>NCT03307629</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer</brief_title>
  <official_title>NOX66 and Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer - a Phase 1b Proof of Concept and Dose Confirmation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noxopharm Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Noxopharm Limited</source>
  <oversight_info>
    <has_dmc>No</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 study is intended as a Proof of Concept and dose confirmation study. The primary&#xD;
      objective of this study is to observe safety and tolerability of idronoxil (NOX66) in&#xD;
      combination with radiotherapy (at palliative doses) in patients with metastatic&#xD;
      castrate-resistant prostate cancer (CRPC) and to confirm dose in order to progress to Phase&#xD;
      2/3.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate three escalating doses of NOX66 in combination with palliative&#xD;
      dose of radiation therapy to establish safety profile and / or obtain efficacy signals and to&#xD;
      determine the optimal dose for future radiation therapy combination studies.&#xD;
&#xD;
      The key hypotheses to be tested in this study are:&#xD;
&#xD;
        1. That NOX66 can be safely added to palliative dose radiation therapy.&#xD;
&#xD;
        2. That NOX66 may sensitise tumours to palliative doses of radiation therapy&#xD;
&#xD;
        3. That NOX66 in combination with radiation therapy may trigger or augment an abscopal&#xD;
           effect&#xD;
&#xD;
      Participants will have a minimum of 1 symptomatic lesion amenable to radiation therapy.&#xD;
&#xD;
      Radiation therapy will be delivered at a 20Gy dosage over 5 fractions. NOX66 will be taken on&#xD;
      13 consecutive days starting 1 day prior to radiotherapy.&#xD;
&#xD;
      The response of irradiated and non-irradiated target tumour lesions will be measured by&#xD;
      CT/MRI scan and RECIST1.1 criteria at three time points post treatment. Pain response will be&#xD;
      evaluated using the Brief Pain Inventory-Short Form (BPI-SF) instrument at five time points&#xD;
      post treatment.&#xD;
&#xD;
      Patients will be suitable for the study as they become indicated for palliative radiation&#xD;
      therapy for management of their cancer.&#xD;
&#xD;
      This study will enrol up to 24 patients in 3 NOX66 dose level cohorts of 4 patients (n=12)&#xD;
      and an expansion cohort of 12 patients. Dose escalation decisions will be based on patients&#xD;
      who experience adverse events directly related to NOX66 treatment.&#xD;
&#xD;
      Following the review of accumulated safety data, disease status and treatment efficacy&#xD;
      signals at WEEK 6 for the first 12 patients, the Study Steering Committee will determine the&#xD;
      dose at which to continue treatment for the expansion patient Cohort 4 in the study. A&#xD;
      further 12 patients will be recruited at this dose level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">September 15, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of incidence of Treatment-Emergent Adverse Events including SAEs [Safety and Tolerability] of NOX66 combined with radiation therapy between multiple timepoints</measure>
    <time_frame>Day 2, Day 6, EOT and from enrolment up to week 6, week 12, week 24</time_frame>
    <description>Safety will be assessed through reported incidence of treatment emergent adverse events (AEs), including SAEs, dose limiting toxicities, AEs leading to withdrawal, events of at least CTCAE Version 4.03 Grade 2 in severity. Treatment emergent AEs are those with an onset on or after the initiation of therapy. Timepoints for AE /SAE assessment are Day 2 (start of radiation therapy treatment and one day after start of NOX66 treatment), Day 6, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of laboratory results</measure>
    <time_frame>Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.</time_frame>
    <description>Other safety endpoints include laboratory results which are assessed at Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of ECG results</measure>
    <time_frame>Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.</time_frame>
    <description>Further safety endpoints include laboratory results and ECG findings which are assessed Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of tumour size in patients according to RECIST 1.1 criteria</measure>
    <time_frame>From enrolment up to week 6, week 12, week 24</time_frame>
    <description>RECIST response in target irradiated and non-irradiated lesions based on radiographic CT/MRI scan. RECIST 1.1 criteria are Complete Response (CR), Partial Response (PR), Stable Disease(SD) and Progressive Disease (PD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of non-target lesions according to RECIST 1.1 criteria</measure>
    <time_frame>From enrolment up to week 6, week 12, week 24</time_frame>
    <description>RECIST 1.1 assessment of response in Non-target lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response according to RECIST 1.1 criteria</measure>
    <time_frame>From enrolment up to week 6, week 12, week 24</time_frame>
    <description>Overall RECIST 1.1 response based on combined assessment criteria for target, non-target and new lesions lesions as Complete Response (CR), Partial Response (PR), Stable Disease(SD) and Progressive Disease (PD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overall pain score assessment by using BPI-SF</measure>
    <time_frame>From enrolment up to week 6, week 12, week 18, week 24</time_frame>
    <description>Change from baseline in pain score based on responses to BPI-SF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase or decrease of Prostate Specific Antigen (PSA) levels</measure>
    <time_frame>From enrolment up to week 6, week 12, week 24</time_frame>
    <description>Change from baseline in serum PSA levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of ECOG value</measure>
    <time_frame>From enrolment up to week 6, week 12, week 24</time_frame>
    <description>Assessment of patient via ECOG status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of change in physical appearance (physical exam) by measuring HEENT, gastrointestinal, abdominal status on multiple timepoints</measure>
    <time_frame>From enrolment up to Day 2, End of Treatment (day 16-17), week 6, week 12, week 24</time_frame>
    <description>Assessment of patient via physical exam.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>NOX66 + Radiation treatment (combined) in cohorts 1-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle.&#xD;
NOX66 treatment given to 3 cohorts of 4 patients as 1 of 3 doses, 400mg, 800mg and 1200 mg.&#xD;
Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOX66 + Radiation treatment (combined) in cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle.&#xD;
NOX66 dose will be either one of 3 doses 400mg, 800mg and 1200 mg based on interim analyses of safety data and tumour response at WEEK 6 of 3 dose cohorts of 12 total patients. The Safety Steering Committee will inform on dose for cohort expansion.&#xD;
Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NOX66</intervention_name>
    <description>NOX66 delivered as rectal suppository.</description>
    <arm_group_label>NOX66 + Radiation treatment (combined) in cohort 4</arm_group_label>
    <arm_group_label>NOX66 + Radiation treatment (combined) in cohorts 1-3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Irradiation Therapy</intervention_name>
    <description>Radiation per selected tumour lesion.</description>
    <arm_group_label>NOX66 + Radiation treatment (combined) in cohort 4</arm_group_label>
    <arm_group_label>NOX66 + Radiation treatment (combined) in cohorts 1-3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent&#xD;
&#xD;
          2. ≥ 18 years of age&#xD;
&#xD;
          3. Histologically confirmed prostate cancer and/or PSA of &gt;100 ng/mL at original&#xD;
             diagnosis&#xD;
&#xD;
          4. Metastatic disease evidenced by either CT/MRI imaging or bone scan&#xD;
&#xD;
          5. Objective evidence of disease progression as defined by either:&#xD;
&#xD;
             i. Radiographic progression of in nodal or visceral metastases and bone disease&#xD;
             progression with 2 or more new lesions ii. Rising PSA value ≥2ng/ml in at least 3&#xD;
             measurements, at least 1 week apart, with castrate levels of serum testosterone.&#xD;
&#xD;
          6. Eligible to receive palliative radiation therapy for management of disease&#xD;
&#xD;
          7. At least one symptomatic lesion which is suitable for radiation therapy&#xD;
&#xD;
          8. ECOG Performance status 0-2&#xD;
&#xD;
          9. A minimum life expectancy of 24 weeks&#xD;
&#xD;
         10. Adequate bone marrow, hepatic and renal function as evidenced by:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &gt; 1.5 x 109/L&#xD;
&#xD;
               -  Platelet count &gt; 100 x 109/L&#xD;
&#xD;
               -  Hemoglobin &gt; 9.0 g/dL&#xD;
&#xD;
               -  Serum bilirubin &lt; 1.5 x ULN&#xD;
&#xD;
               -  AST/ALT (SGOT/SGPT) &lt; 2.5 x ULN for the reference laboratory or &lt; 5 x ULN in the&#xD;
                  presence of liver metastases&#xD;
&#xD;
               -  Serum creatinine &lt; 1.5 x ULN&#xD;
&#xD;
         11. Ongoing androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH)&#xD;
             agonist or antagonist&#xD;
&#xD;
         12. At least 4 weeks must have elapsed prior to commencement of NOX66 treatment since&#xD;
             prior chemotherapy, investigational drug or biologic therapy and any toxicity&#xD;
             associated with these treatments has recovered to ≤ NCI-CTCAE (version 4.03) Grade 1.&#xD;
&#xD;
         13. At least 21 days must have elapsed following major surgery and any surgical incision&#xD;
             should be completely healed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Tumour involvement of the central nervous system&#xD;
&#xD;
          2. Uncontrolled infection or systemic disease&#xD;
&#xD;
          3. Clinically significant cardiac disease not well controlled with medication (e.g.&#xD;
             congestive heart failure, symptomatic coronary artery disease, angina, and cardiac&#xD;
             arrhythmias) or myocardial infarction within the last 12 months&#xD;
&#xD;
             • Patients with a QTc &gt; 470 msec on screening ECG&#xD;
&#xD;
          4. Concurrent systemic chemotherapy or biological therapy&#xD;
&#xD;
          5. Any situation where the use of suppository therapy is contra-indicated or impractical&#xD;
             (eg. chronic diarrhoea, colostomy, ulcerative colitis).&#xD;
&#xD;
          6. Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously&#xD;
             treated or both)&#xD;
&#xD;
          7. Any subject whose testosterone is not suppressed i.e. is &gt; 0.5nmols/L&#xD;
&#xD;
          8. Any other reason which, in the opinion of the investigator, will preclude suitable&#xD;
             participation in the study.&#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>Marinella Messina, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Noxopharm Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Genesis Cancer Care - Newcastle</name>
      <address>
        <city>Newcastle</city>
        <state>New South Wales</state>
        <zip>2290</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central West Cancer Care Centre - Orange Health Service</name>
      <address>
        <city>Orange</city>
        <state>New South Wales</state>
        <zip>2800</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Cancer Care Mater Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2060</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North West Cancer Centre, Tamworth Hospital</name>
      <address>
        <city>Tamworth</city>
        <state>New South Wales</state>
        <zip>2340</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Centres Gold Coast</name>
      <address>
        <city>Gold Coast</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Clinical Medicine</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TSMU The First University Clinic</name>
      <address>
        <city>Tbilisi</city>
        <zip>0141</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center of Urology</name>
      <address>
        <city>Tbilisi</city>
        <zip>0144</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Personalised Medicine</name>
      <address>
        <city>Tbilisi</city>
        <zip>0186</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canterbury Urology Research Trust</name>
      <address>
        <city>Christchurch</city>
        <zip>8013</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Georgia</country>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>September 20, 2020</last_update_submitted>
  <last_update_submitted_qc>September 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 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>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for primary and secondary outcome measure will be made available within 12 months after study completion.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>12 months after study completion</ipd_time_frame>
  </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/NCT03307629
org study id: NOX66-002A
nct id: NCT03307629
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is intended as a Proof of Concept and dose confirmation study. The primary
      objective of this study is to observe safety and tolerability of idronoxil (NOX66) in
      combination with radiotherapy (at palliative doses) in patients with metastatic
      castrate-resistant prostate cancer (CRPC) and to confirm dose in order to progress to Phase
      2/3.
This study will investigate three escalating doses of NOX66 in combination with palliative
      dose of radiation therapy to establish safety profile and / or obtain efficacy signals and to
      determine the optimal dose for future radiation therapy combination studies.

      The key hypotheses to be tested in this study are:

        1. That NOX66 can be safely added to palliative dose radiation therapy.

        2. That NOX66 may sensitise tumours to palliative doses of radiation therapy

        3. That NOX66 in combination with radiation therapy may trigger or augment an abscopal
           effect

      Participants will have a minimum of 1 symptomatic lesion amenable to radiation therapy.

      Radiation therapy will be delivered at a 20Gy dosage over 5 fractions. NOX66 will be taken on
      13 consecutive days starting 1 day prior to radiotherapy.

      The response of irradiated and non-irradiated target tumour lesions will be measured by
      CT/MRI scan and RECIST1.1 criteria at three time points post treatment. Pain response will be
      evaluated using the Brief Pain Inventory-Short Form (BPI-SF) instrument at five time points
      post treatment.

      Patients will be suitable for the study as they become indicated for palliative radiation
      therapy for management of their cancer.

      This study will enrol up to 24 patients in 3 NOX66 dose level cohorts of 4 patients (n=12)
      and an expansion cohort of 12 patients. Dose escalation decisions will be based on patients
      who experience adverse events directly related to NOX66 treatment.

      Following the review of accumulated safety data, disease status and treatment efficacy
      signals at WEEK 6 for the first 12 patients, the Study Steering Committee will determine the
      dose at which to continue treatment for the expansion patient Cohort 4 in the study. A
      further 12 patients will be recruited at this dose level.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of incidence of Treatment-Emergent Adverse Events including SAEs [Safety and Tolerability] of NOX66 combined with radiation therapy between multiple timepoints
time frame: Day 2, Day 6, EOT and from enrolment up to week 6, week 12, week 24
description: Safety will be assessed through reported incidence of treatment emergent adverse events (AEs), including SAEs, dose limiting toxicities, AEs leading to withdrawal, events of at least CTCAE Version 4.03 Grade 2 in severity. Treatment emergent AEs are those with an onset on or after the initiation of therapy. Timepoints for AE /SAE assessment are Day 2 (start of radiation therapy treatment and one day after start of NOX66 treatment), Day 6, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.
measure: Assessment of laboratory results
time frame: Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.
description: Other safety endpoints include laboratory results which are assessed at Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.
measure: Assessment of ECG results
time frame: Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.
description: Further safety endpoints include laboratory results and ECG findings which are assessed Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.
measure: Change of tumour size in patients according to RECIST 1.1 criteria
time frame: From enrolment up to week 6, week 12, week 24
description: RECIST response in target irradiated and non-irradiated lesions based on radiographic CT/MRI scan. RECIST 1.1 criteria are Complete Response (CR), Partial Response (PR), Stable Disease(SD) and Progressive Disease (PD)
measure: Change of non-target lesions according to RECIST 1.1 criteria
time frame: From enrolment up to week 6, week 12, week 24
description: RECIST 1.1 assessment of response in Non-target lesions
measure: Overall response according to RECIST 1.1 criteria
time frame: From enrolment up to week 6, week 12, week 24
description: Overall RECIST 1.1 response based on combined assessment criteria for target, non-target and new lesions lesions as Complete Response (CR), Partial Response (PR), Stable Disease(SD) and Progressive Disease (PD)
measure: Change in overall pain score assessment by using BPI-SF
time frame: From enrolment up to week 6, week 12, week 18, week 24
description: Change from baseline in pain score based on responses to BPI-SF
measure: Increase or decrease of Prostate Specific Antigen (PSA) levels
time frame: From enrolment up to week 6, week 12, week 24
description: Change from baseline in serum PSA levels
measure: Change of ECOG value
time frame: From enrolment up to week 6, week 12, week 24
description: Assessment of patient via ECOG status
measure: Assessment of change in physical appearance (physical exam) by measuring HEENT, gastrointestinal, abdominal status on multiple timepoints
time frame: From enrolment up to Day 2, End of Treatment (day 16-17), week 6, week 12, week 24
description: Assessment of patient via physical exam.
arm group label: NOX66 + Radiation treatment (combined) in cohorts 1-3
arm group type: Experimental
description: NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle.
NOX66 treatment given to 3 cohorts of 4 patients as 1 of 3 doses, 400mg, 800mg and 1200 mg.
Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.
arm group label: NOX66 + Radiation treatment (combined) in cohort 4
arm group type: Experimental
description: NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle.
NOX66 dose will be either one of 3 doses 400mg, 800mg and 1200 mg based on interim analyses of safety data and tumour response at WEEK 6 of 3 dose cohorts of 12 total patients. The Safety Steering Committee will inform on dose for cohort expansion.
Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.
intervention type: Drug
intervention name: NOX66
description: NOX66 delivered as rectal suppository.
arm group label: NOX66 + Radiation treatment (combined) in cohort 4
arm group label: NOX66 + Radiation treatment (combined) in cohorts 1-3
intervention type: Radiation
intervention name: Irradiation Therapy
description: Radiation per selected tumour lesion.
arm group label: NOX66 + Radiation treatment (combined) in cohort 4
arm group label: NOX66 + Radiation treatment (combined) in cohorts 1-3
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marinella Messina, PhD
role: Study Chair
affiliation: Noxopharm Limited
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Georgia
country: New Zealand
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: De-identified individual participant data for primary and secondary outcome measure will be made available within 12 months after study completion.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 12 months after study completion