CancerPhase 1NCT03307629

Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer

A Phase 1 study testing NOX66 and Irradiation Therapy in people with Cancer, run by Noxopharm Limited at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Cancer
What is being tested?: NOX66 and Irradiation Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 10 sitesin 3 countries
Study dates: 1 Nov 2017to 15 Sep 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent
≥ 18 years of age
Histologically confirmed prostate cancer and/or PSA of >100 ng/mL at original diagnosis
Metastatic disease evidenced by either CT/MRI imaging or bone scan
Objective evidence of disease progression as defined by either:
Radiographic progression of in nodal or visceral metastases and bone disease progression with 2 or more new lesions ii. Rising PSA value ≥2ng/ml in at least 3 measurements, at least 1 week apart, with castrate levels of serum testosterone.

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Eligible to receive palliative radiation therapy for management of disease
At least one symptomatic lesion which is suitable for radiation therapy
ECOG Performance status 0-2
A minimum life expectancy of 24 weeks
Adequate bone marrow, hepatic and renal function as evidenced by:
Absolute neutrophil count (ANC) > 1.5 x 109/L
Platelet count > 100 x 109/L
Hemoglobin > 9.0 g/dL
Serum bilirubin < 1.5 x ULN
AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
Serum creatinine < 1.5 x ULN
Ongoing androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
At least 4 weeks must have elapsed prior to commencement of NOX66 treatment since prior chemotherapy, investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to ≤ NCI-CTCAE (version 4.03) Grade 1.
At least 21 days must have elapsed following major surgery and any surgical incision should be completely healed.

Who cannot join

Tumour involvement of the central nervous system
Uncontrolled infection or systemic disease
Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease, angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months
Patients with a QTc > 470 msec on screening ECG
Concurrent systemic chemotherapy or biological therapy
Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis).

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Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
Any subject whose testosterone is not suppressed i.e. is > 0.5nmols/L
Any other reason which, in the opinion of the investigator, will preclude suitable participation in the study.

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

Australia5 sites

Radiation Oncology Centres Gold Coast
Gold Coast, Queensland, 4215
Genesis Cancer Care - Newcastle
Newcastle, New South Wales, 2290
Central West Cancer Care Centre - Orange Health Service
Orange, New South Wales, 2800
Genesis Cancer Care Mater Hospital
Sydney, New South Wales, 2060
North West Cancer Centre, Tamworth Hospital
Tamworth, New South Wales, 2340

Other trials in Australia

Georgia4 sites

Research Institute of Clinical Medicine
Tbilisi, 0112
TSMU The First University Clinic
Tbilisi, 0141
National Center of Urology
Tbilisi, 0144
Institute for Personalised Medicine
Tbilisi, 0186

Other trials in Georgia

New Zealand1 site

Canterbury Urology Research Trust
Christchurch, 8013

Other trials in New Zealand

About this study

Official title: NOX66 and Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer - a Phase 1b Proof of Concept and Dose Confirmation Study

Read the detailed description

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:

That NOX66 can be safely added to palliative dose radiation therapy.
That NOX66 may sensitise tumours to palliative doses of radiation therapy
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.

Conditions: Cancer
Being tested: NOX66, Irradiation Therapy
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NOX66Drug
NOX66 delivered as rectal suppository.
Irradiation TherapyRadiation
Radiation per selected tumour lesion.

Study groups in NCT03307629
Study group	Role	What they receive
NOX66 + Radiation treatment (combined) in cohorts 1-3	Experimental	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. Receives: Drug: NOX66; Radiation: Irradiation Therapy
NOX66 + Radiation treatment (combined) in cohort 4	Experimental	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. Receives: Drug: NOX66; Radiation: Irradiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints
Safety will be assessed through reported incidence of treatment emergent adverse events (AEs), including SAEs, dose limiting toxicities, AEs leading to withdrawal, events that are greater than 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), Week 6, Week 12, and Week 24.
Measured: Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24
Assessment of Laboratory Results
Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.
Measured: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.
Assessment of ECG Results
Mean change from Baseline in ECG intervals (msec) which are assessed at End of treatment (Day 16), Week 12, and Week 24.
Measured: Baseline to End of treatment (Day 16), Week 12, and Week 24.

Secondary outcomes (7)

Change of Target Lesions in Participants According to RECIST 1.1 Criteria
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). Not Applicable (NA) indicates that a participant did not have measurable target lesions at Screening.
Measured: Week 6, Week 12, and Week 24
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria
RECIST 1.1 assessment of response in Non-Target Lesions as Complete Response (CR), Non-CR/Non-PD, or Progressive Disease (PD). Not Applicable (NA) signifies that the participant did not have non-target lesions at Screening.
Measured: Week 6, Week 12, and Week 24
Overall Response According to RECIST 1.1 Criteria
Overall RECIST 1.1 response based on combined assessment criteria for target, non-target and new lesions as Complete Response (CR), Partial Response (PR), Stable Disease(SD), or Progressive Disease (PD)
Measured: From enrolment up to Week 6, Week 12, and Week 24
Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF)
Percentage change from baseline in overall pain score based on responses to the BPI-SF, which is scored from 0 to 10, with 0 = no pain and 10 = the most severe pain imaginable.
Measured: From enrolment up to Day 16, Week 6, Week 12, and Week 24
Change in Prostate Specific Antigen (PSA) Levels
Percentage change from baseline in serum PSA levels (ng/mL) at Week 6, Week 12, and Week 24
Measured: From enrolment up to Week 6, Week 12, and Week 24
Change of ECOG Performance Status
Assessment of patient via ECOG Performance Status, which has a scale scored from 0 (Fully Active) to 5 (Dead).
Measured: From enrolment up to Week 6, Week 12, and Week 24
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints
Assessment of patient via physical exam comparing Day 2, End of Treatment (Day 16), Week 6, Week 12, and Week 24 to baseline. Physical exam included abdominal, cardiovascular, dermatologic, gastrointestinal, genitourinary, HEENT (head, eyes, ears, nose, throat), lymphatic, musculoskeletal, neurological, other, and pulmonary exams.
Measured: From enrolment up to Day 2, End of Treatment (Day 16), Week 6, Week 12, and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201715 Sep 2020

First posted12 Oct 2017
Study start1 Nov 2017
Primary completion1 Dec 2019
Study completion15 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03307629
Sponsor's protocol ID: NOX66-002A
Status last verified: Jul 2025
First submitted: 27 Sep 2017
Last updated: 29 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data for primary and secondary outcome measure will be made available within 12 months after study completion.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NOX66 and Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer - a Phase 1b Proof of Concept and Dose Confirmation Study
ClinicalTrials.gov ID: NCT03307629
Acronym / sponsor ID: NOX66-002A
Conditions: Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Noxopharm LimitedIndustry (pharma, biotech, devices)
Study start: 1 Nov 2017 (actual)
Primary completion: 1 Dec 2019 (actual)
Study completion: 15 Sep 2020 (actual)
First posted: 12 Oct 2017 (actual)
Results: Posted 29 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The key hypotheses to be tested in this study are:

That NOX66 can be safely added to palliative dose radiation therapy.
That NOX66 may sensitise tumours to palliative doses of radiation therapy
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.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NOX66 + Radiation treatment (combined) in cohorts 1-3	Experimental	Drug: NOX66, Radiation: Irradiation TherapyNOX66 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.
NOX66 + Radiation treatment (combined) in cohort 4	Experimental	Drug: NOX66, Radiation: Irradiation TherapyNOX66 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Provision of informed consent
≥ 18 years of age
Histologically confirmed prostate cancer and/or PSA of >100 ng/mL at original diagnosis
Metastatic disease evidenced by either CT/MRI imaging or bone scan
Objective evidence of disease progression as defined by either:

Key exclusion criteria (9 listed)

Tumour involvement of the central nervous system
Uncontrolled infection or systemic disease
Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease, angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months
Concurrent systemic chemotherapy or biological therapy
Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NOX66NOX66 delivered as rectal suppository.	Drug	NOX66 + Radiation treatment (combined) in cohort 4, NOX66 + Radiation treatment (combined) in cohorts 1-3
Irradiation TherapyRadiation per selected tumour lesion.	Radiation	NOX66 + Radiation treatment (combined) in cohort 4, NOX66 + Radiation treatment (combined) in cohorts 1-3

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints
Time frame: Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24
Safety will be assessed through reported incidence of treatment emergent adverse events (AEs), including SAEs, dose limiting toxicities, AEs leading to withdrawal, events that are greater than 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), Week 6, Week 12, and Week 24.
Assessment of Laboratory Results
Time frame: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.
Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.
Assessment of ECG Results
Time frame: Baseline to End of treatment (Day 16), Week 12, and Week 24.
Mean change from Baseline in ECG intervals (msec) which are assessed at End of treatment (Day 16), Week 12, and Week 24.

7 secondary outcomes

Change of Target Lesions in Participants According to RECIST 1.1 Criteria
Time frame: Week 6, Week 12, and Week 24
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria
Time frame: Week 6, Week 12, and Week 24
Overall Response According to RECIST 1.1 Criteria
Time frame: From enrolment up to Week 6, Week 12, and Week 24
Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF)
Time frame: From enrolment up to Day 16, Week 6, Week 12, and Week 24
Change in Prostate Specific Antigen (PSA) Levels
Time frame: From enrolment up to Week 6, Week 12, and Week 24
Change of ECOG Performance Status
Time frame: From enrolment up to Week 6, Week 12, and Week 24
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints
Time frame: From enrolment up to Day 2, End of Treatment (Day 16), Week 6, Week 12, and Week 24

Results and safety

Results posted to the registry on 29 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 - NOX66 400mg Daily	4	4
Cohort 2 - NOX66 800mg Daily	6	3
Cohort 3 - NOX66 1200mg Daily	4	4
Cohort 4 - NOX66 1200mg Daily	11	5

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints

Time frame: Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24. Count of participants. Unit: Participants

Measure	Cohort 1 - NOX66 400mg Daily n = 4	Cohort 2 - NOX66 800mg Daily n = 6	Cohort 3 - NOX66 1200mg Daily n = 4	Cohort 4 - NOX66 1200mg Daily n = 11
Adverse events (AEs)	4	5	2	9
Treatment-emergent adverse events (TEAEs)	4	5	2	9
AEs that were DLTs	0	0	0	0
AEs leading to withdrawal	0	0	0	0
AEs that were greater than Grade 2 severity	1	3	1	6
Serious adverse events (SAEs)	0	3	1	1

Population analysed: Safety population = all participants who received at least one dose of NOX66

Primary outcome: Assessment of Laboratory Results

Time frame: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.. Mean (Standard Deviation). Unit: micromol/L

Measure	Cohort 1 - NOX66 400mg Daily n = 4	Cohort 2 - NOX66 800mg Daily n = 6	Cohort 3 - NOX66 1200mg Daily n = 4	Cohort 4 - NOX66 1200mg Daily n = 11
Direct Bilirubin, Day 16 (micromol/L)	0.33 (0.583)	-0.78 (1.487)	-0.08 (0.415)	0.16 (0.494)
Direct Bilirubin, Week 6 (micromol/L)	0.33 (0.481)	-0.68 (0.864)	-0.26 (0.497)	-0.09 (0.320)
Direct Bilirubin, Week 12 (micromol/L)	-0.12 (0.872)	-0.46 (0.173)	-0.39 (0.521)	0.19 (0.929)
Direct Bilirubin, Week 24 (micromol/L)	-0.03 (0.227)	-0.70 (0.735)	-0.26 (0.549)	0.05 (0.135)
Total Bilirubin, Day 16 (micromol/L)	1.85 (2.229)	-0.35 (3.488)	-0.63 (2.447)	-0.26 (0.831)
Total Bilirubin, Week 6 (micromol/L)	2.45 (1.937)	0.59 (0.897)	-0.48 (1.754)	-0.76 (1.120)
Total Bilirubin, Week 12 (micromol/L)	-1.12 (3.749)	0.90 (1.137)	1.46 (2.034)	-0.92 (1.915)
Total Bilirubin, Week 24 (micromol/L)	-1.35 (2.928)	-0.30 (0.567)	-1.43 (3.404)	-1.28 (2.483)

Population analysed: Safety population = all patients who received at least one dose of NOX66

Primary outcome: Assessment of ECG Results

Time frame: Baseline to End of treatment (Day 16), Week 12, and Week 24.. Mean (Standard Deviation). Unit: msec

Measure	Cohort 1 - NOX66 400mg Daily n = 4	Cohort 2 - NOX66 800mg Daily n = 6	Cohort 3 - NOX66 1200mg Daily n = 4	Cohort 4 - NOX66 1200mg Daily n = 11
QT interval, Day 16	24.1 (55.08)	-1.4 (33.29)	9 (22.16)	16.1 (33.53)
QT interval, Week 12	33.9 (68.59)	4.8 (13.62)	-7 (23.67)	7.6 (36.6)
QT interval, Week 24	9.7 (34.76)	4.8 (27.69)	5.2 (25.62)	9.2 (12.55)
QTc interval, Day 16	19 (48.92)	19.7 (32.1)	11.1 (8.12)	17.9 (40.32)
QTc interval, Week 12	29.5 (30.88)	17.0 (24.99)	12.7 (6.39)	15 (25.5)
QTc interval, Week 24	23.3 (29.57)	-2.6 (14.34)	6.1 (11.55)	0.8 (16.61)
RR interval, Day 16	23.4 (50.15)	-56.4 (123.08)	7.6 (66.68)	4.5 (212.55)
RR interval, Week 12	35.1 (201.4)	-11.6 (150.02)	-55.6 (140.05)	-20.1 (181.42)

Population analysed: Safety population = all patients who received at least one dose of NOX66

Primary outcome: Assessment of Laboratory Results

Time frame: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.. Mean (Standard Deviation). Unit: (g/L

Measure	Cohort 1 - NOX66 400mg Daily n = 4	Cohort 2 - NOX66 800mg Daily n = 6	Cohort 3 - NOX66 1200mg Daily n = 4	Cohort 4 - NOX66 1200mg Daily n = 11
Haemoglobin, Day 16 (g/L)	-0.5 (5.066)	-6.17 (9.579)	1.5 (10.083)	-11.27 (8.956)
Haemoglobin, Week 6 (g/L)	-7.25 (13.598)	-8.50 (17.540)	-4.75 (10.532)	-11.27 (8.810)
Haemoglobin, Week 12 (g/L)	11.00 (14.855)	4.75 (21.140)	-6.00 (6.083)	-7.45 (15.247)
Haemoglobin, Week 24 (g/L)	3.50 (6.608)	-2.00 (21.932)	-4.25 (6.397)	-14.60 (23.341)
Mean Corpuscular Haemoglobin Concentration, Day 16 (g/L)	-16.75 (34.267)	-2.40 (8.989)	-4.33 (12.662)	0.73 (3.062)
Mean Corpuscular Haemoglobin Concentration, Week 6 (g/L)	16.75 (38.922)	-4.25 (11.325)	1.67 (2.082)	-2.00 (9.960)
Mean Corpuscular Haemoglobin Concentration, Week 12 (g/L)	-13.00 (29.178)	-6.00 (8.888)	-1.33 (12.702)	-8.09 (28.339)
Mean Corpuscular Haemoglobin Concentration, Week 24 (g/L)	-5.5 (31.754)	-2.67 (6.506)	-2.67 (8.622)	-0.80 (11.756)

Population analysed: Safety population = all patients who received at least one dose of NOX66

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Individual subjects = 9 months. Entire study = 19 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - NOX66 400mg Daily	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Cohort 2 - NOX66 800mg Daily	3 of 6 (50%)	5 of 6 (83.3%)	3 of 6
Cohort 3 - NOX66 1200mg Daily	1 of 4 (25%)	2 of 4 (50%)	0 of 4
Cohort 4 - NOX66 1200mg Daily	1 of 11 (9.1%)	9 of 11 (81.8%)	1 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data for primary and secondary outcome measure will be made available within 12 months after study completion.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marinella Messina, PhD study chair

Noxopharm Limited

10 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NOX66 and Irradiation Therapy in people with Cancer, run by Noxopharm Limited at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia, Georgia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints (time frame: Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03307629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.