drugset / Trial / NCT03307629
Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-11-01
- Primary completion
- 2019-12-01
- Completion
- 2020-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NOX66 | Small molecule | 400 mg | Rectal |
| Subject | NOX66 | Small molecule | 800 mg | Rectal |
| Subject | NOX66 | Small molecule | 1200 mg | Rectal |