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Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer

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: NCT03041285
Recruitment Status : Terminated (have difficulty finding eligible participants)
First Posted : February 2, 2017
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Associate Professor Thomas Eade, Royal North Shore Hospital

Brief Summary:
The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in combination with palliative radiotherapy for metastatic prostate cancer

Condition or disease Intervention/treatment Phase
Metastatic Castrate- Resistant Prostate Cancer Drug: idronoxil (NOX66) suppository Radiation: Stereotactic Body Radiation Therapy Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
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.
Masking: None (Open Label)
Masking Description: There is no masking.
Primary Purpose: Treatment
Official Title: Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
Actual Study Start Date : August 31, 2017
Actual Primary Completion Date : September 17, 2019
Actual Study Completion Date : September 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Group 1 NOX66 400mg and SBRT
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.
Drug: idronoxil (NOX66) suppository

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.

.

Other Name: NOX66

Radiation: Stereotactic Body Radiation Therapy
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.

Experimental: Group 2 NOX66 800mg and SBRT
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.
Drug: idronoxil (NOX66) suppository

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.

.

Other Name: NOX66

Radiation: Stereotactic Body Radiation Therapy
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.




Primary Outcome Measures :
  1. safety of Idronoxil dose escalation [ Time Frame: From start of NOX66 with stereotactic radiotherapy up to three months post treatment. ]
    Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3


Secondary Outcome Measures :
  1. evidence of clinical tumour response [ Time Frame: 3 months post treatment ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed metastatic prostate cancer that is castrate-resistant.
  • 2-3 lesions suitable for radiotherapy.
  • ECOG Performance status 0-2.

    • Adequate bone marrow, hepatic and renal function
    • At least 4 weeks must have elapsed prior to commencement of idronoxil treatment since prior chemotherapy, investigational drug or biologic therapy

Exclusion Criteria:

  • Chemotherapy regimens with delayed toxicity within the last 4 weeks.
  • Any situation where the use of suppository therapy is contra-indicated or impractical(eg. chronic diarrhoea, colostomy, ulcerative colitis).
  • No concurrent systemic chemotherapy or biologic therapy is allowed.
  • Psychiatric disorder or social or geographic situation that would preclude study participation.
  • Patient unable to provide consent

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): NCT03041285


Locations
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Australia, New South Wales
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
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Principal Investigator: Thomas Eade Northern Sydney Local Health District
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Responsible Party: Associate Professor Thomas Eade, Principal Investigator, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT03041285    
Other Study ID Numbers: NOX66 version 1
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases