drugset / Trial / NCT06463457
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
Phase 2
Active not recruiting
33 enrolled
Atish Choudhury, MD
Bayer · collabNational Comprehensive Cancer Network · collabPfizer · collabSumitomo Pharma America, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when administered in combination. The names of the drugs in this study are: * Relugolix (a type of gonadotropin-releasing hormone receptor antagonist) * Darolutamide (a type of androgen receptor antagonist)
Timeline
- Start
- 2024-12-13
- Primary completion
- 2028-11-30
- Completion
- 2028-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | — | Oral |
| Subject | Relugolix | Small molecule | — | Oral |