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NCT05999968 · ClinicalTrials.gov registry record · Phase 1
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
A Phase 1 study of Prostatic Neoplasms, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 13
- Study locations
NCT05999968: Completed Phase 1 study of Prostatic Neoplasms, sponsored by Eli Lilly and Company.
NCT05999968 is a Phase 1 study of Prostatic Neoplasms that has completed, run by Eli Lilly and Company. The registered enrollment target is 10 participants, below the 514-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (98% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05999968, a Phase 1 study of Prostatic Neoplasms, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
Conditions Studied
Interventions
- DRUG Darolutamide
- DRUG Abemaciclib
- DRUG LHRH agonist/antagonist
Study Locations (13)
Other
- Universitaetsklinikum Hamburg-Eppendorf - Hamburg
- Hospital Infanta Cristina - Badajoz
- Hospital Universitario Virgen Del Rocio - Seville
Madrid, Comunidad de
- Hospital General Universitario Gregorio Marañon - Madrid
- Hospital Universitario Ramón y Cajal - Madrid
- Hospital Universitario 12 de Octubre - Madrid
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island - Mineola
- Laura and Isaac Perlmutter Cancer Center - New York
Arkansas
- Highlands Oncology Group - Springdale
Baden-Wurttemberg
- Studienpraxis Urologie - Nürtingen
Bavaria
- Klinikum Rechts Der Isar Der Technischen Universität München - Munich
Schleswig-Holstein
- Universitätsklinikum Schleswig-Holstein - Lübeck
Catalunya [Cataluña]
- Instituto Catalan de Oncologia - Hospital Duran i Reynals - L'Hospitalet de Llobregat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-01-12 |
| Est. Completion | 2026-01-21 |
| Phase | Phase 1 |
What the finished NCT05999968 record still lists
NCT05999968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 514-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Darolutamide is the first listed.
NCT05999968 lists 13 locations in 8 states (Other, Madrid, Comunidad de, New York).
Frequently Asked Questions
What is clinical trial NCT05999968 about?
NCT05999968 is a clinical study titled "Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment". 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.
What is the current status of trial NCT05999968?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-01-12. Estimated completion is 2026-01-21.
What conditions does trial NCT05999968 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT05999968?
The interventions under investigation include: Darolutamide (DRUG), Abemaciclib (DRUG), LHRH agonist/antagonist (DRUG).
Who is sponsoring clinical trial NCT05999968?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05999968 being conducted?
This trial has 13 study locations across Arkansas, New York, Baden-Wurttemberg, Bavaria, Schleswig-Holstein. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05999968's enrollment target sits among peer trials
10 64th of 65 higher than 2 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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