Phase 1
Completed N=25
Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer
Cancer
Source: ClinicalTrials.gov NCT03307629 ↗
Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Jul 2025
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints — 4; 5; 2; 9 Participants
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 order to progress to Phase 2/3.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints |
4; 5; 2; 9; 4; 5 | — |
| PRIMARY Assessment of Laboratory Results |
-2.10; -0.65; -0.180; -1.52; -2.60; 1.25 | — |
| PRIMARY Assessment of ECG Results |
24.1; -1.4; 9; 16.1; 33.9; 4.8 | — |
| SECONDARY Change of Target Lesions in Participants According to RECIST 1.1 Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria |
0; 0; 0; 0; 4; 5 | — |
| SECONDARY Overall Response According to RECIST 1.1 Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) |
-52.186; 32.737; 3.6; -37.2; -58.954; -47.815 | — |
| SECONDARY Change in Prostate Specific Antigen (PSA) Levels |
17.79; -46.67; 0.29; -19.49; 35.75; -53.26 | — |
| SECONDARY Change of ECOG Performance Status |
0; 0; 2; 2; 4; 6 | — |
| SECONDARY Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints |
0; 0; 0; 0; 4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- 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:
i. 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.
- 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 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).
- 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.
Data sourced from ClinicalTrials.gov (NCT03307629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.