Clinical Trial: NCT05999968
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
Status:
TERMINATEDPhase:
Phase 1| Lead Sponsor: | Eli Lilly and Company |
| Information Provided By: | Eli Lilly and Company |
| Last Update Posted: | 2026-06-26 |
Study Overview
Brief 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.
Official Title
A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer
Conditions
Prostatic Neoplasms
Intervention / Treatment
- Drug: Abemaciclib
- Drug: Darolutamide
- Drug: LHRH agonist/antagonist
Other Study ID Numbers
- 18714
- I3Y-MC-JPEI
- 2023-503919-15-00
- U1111-1294-1466
- 2023
Start Date (Actual)
2024-01-12
Primary Completion Date (Actual)
2024-02-23
Study Completion Date (Actual)
2026-01-21
Enrollment (Actual)
10
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Eli Lilly and Company |
| Information Provided By: | Eli Lilly and Company |
| Last Update Posted: | 2026-06-26 |
Study Overview
Brief 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.
Official Title
A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer
Conditions
Prostatic Neoplasms
Intervention / Treatment
- Drug: Abemaciclib
- Drug: Darolutamide
- Drug: LHRH agonist/antagonist
Other Study ID Numbers
- 18714
- I3Y-MC-JPEI
- 2023-503919-15-00
- U1111-1294-1466
- 2023
Start Date (Actual)
2024-01-12
Primary Completion Date (Actual)
2024-02-23
Study Completion Date (Actual)
2026-01-21
Enrollment (Actual)
10
Study Type
Interventional
Phase
Phase 1