Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer
Summary
This research study is trying to determine the safety and efficacy of the combination of two oral drugs, abemaciclib and darolutamide, with androgen deprivation therapy (ADT) in the treatment of metastatic, non-metastatic, and advanced prostate cancers. The first phase of the study is to establish a recommended dose for the second phase. The names of the study drugs and interventions involved in this study are: * Darolutamide * Abemaciclib * Androgen deprivation therapy (ADT) - this includes several different treatments, including Gonadotropin-Releasing Hormone (GnRH) antagonists and agonists It is expected that about 93 people will take part in the research study. Treatment is expected to last 6 months with a follow up period of up to 4.5 years.
Timeline
- Start
- 2023-08-09
- Primary completion
- 2025-07-15
- Completion
- 2026-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | — | Oral |
| Subject | Darolutamide | Other / unclassified | — | Oral |
| Background | Degarelix | Other / unclassified | — | Subcutaneous |
| Background | Goserelin | Other / unclassified | — | Subcutaneous |
| Background | Leuprolide | Other / unclassified | — | Intramuscular |