Clinical trial · Interventional
Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer
Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
NCT03041285CI-TRIAL-00058433terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): have difficulty finding eligible participants
Summary
Brief summary (as posted)
The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in combination with palliative radiotherapy for metastatic prostate cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castrate- Resistant Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| idronoxil (NOX66) suppository | Drug | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 NOX66 400mg and SBRT
- description
- 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.
- interventionNames
- Drug: idronoxil (NOX66) suppository
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- Group 2 NOX66 800mg and SBRT
- description
- 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.
- interventionNames
- Drug: idronoxil (NOX66) suppository
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.