drugset / Trial / NCT03752099
To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
RandomizedSequentialOpen-labelTreatment
Summary
Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC). Phase 2 - To estimate the PSA50 response rate, defined as a decline in PSA to ≥50% of baseline level, confirmed with a second measurement at least 3 weeks apart (PCWG3).
Timeline
- Start
- 2019-01-18
- Primary completion
- 2023-03-15
- Completion
- 2023-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sabizabulin | Small molecule | 4.5 mg | Oral |
| Subject | Sabizabulin | Small molecule | 9 mg | Oral |
| Subject | Sabizabulin | Small molecule | 18 mg | Oral |
| Subject | Sabizabulin | Small molecule | 27 mg | Oral |
| Subject | Sabizabulin | Small molecule | 36 mg | Oral |
| Subject | Sabizabulin | Small molecule | 45 mg | Oral |