- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03041285
Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer
Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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New South Wales
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St Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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 Names:
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.
|
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 Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety of Idronoxil dose escalation
Time Frame: From start of NOX66 with stereotactic radiotherapy up to three months post treatment.
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Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3
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From start of NOX66 with stereotactic radiotherapy up to three months post treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evidence of clinical tumour response
Time Frame: 3 months post treatment
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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. |
3 months post treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Eade, Northern Sydney Local Health District
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOX66 version 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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