Trials / Completed
CompletedNCT05999968
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. Participation may last up to 32 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abemaciclib | Administered orally. |
| DRUG | Darolutamide | Administered orally. |
| DRUG | LHRH agonist/antagonist | Physician's choice. Administered in accordance with the prescribing information. |
Timeline
- Start date
- 2024-01-12
- Primary completion
- 2024-02-23
- Completion
- 2026-01-21
- First posted
- 2023-08-21
- Last updated
- 2026-03-05
Locations
13 sites across 3 countries: United States, Germany, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05999968. Inclusion in this directory is not an endorsement.