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A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone
The purpose of this study is to access the safety of combining sodium selenite with abiraterone and to see what doses of sodium selenite can be safely combined with abiraterone in treating castration resistant prostate cancer.
Details
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2020-10 |
| Completion | 2023-10 |
Conditions
- Prostate Cancer
- Castrate Resistant Prostate Cancer
Interventions
- Abiraterone Acetate
- Sodium Selenite
- Prednisone
Primary outcomes
- Dose limiting Toxicity (DLT) — 2 weeks
Adverse events will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5. Dose limiting toxicities (DLTs) of the combination of sodium selenite plus abiraterone are defined as: * Any ≥ Grade 3 non-hematologic toxicity (possibly, probably, or definitely-related adverse event) * Any ≥ Grade 3 thrombocytopenia with bleeding * Any ≥ Grade 4 thrombocytopenia persisting \> 7 days * Any ≥ Grade 4 neutropenia persisting \> 7 days * Treatment withdrawal by participant decision, or for safety reasons as deemed necessary by the investigator The DLT outcome will be reported as the number of DLT events by dose cohort occurring within 2 weeks of the beginning of treatment, a number without dispersion.