Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

NCT05999968 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 10 participants
Start Date 2024-01-12
Est. Completion 2026-01-21
Phase Phase 1

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05999968

The ClinicalTrials.gov registry entry for NCT05999968 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05999968 reports 13 study locations spanning 8 distinct geographic areas — top geographies include Other, Madrid, Comunidad de, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05999968?

The interventions under investigation include: Darolutamide (DRUG), Abemaciclib (DRUG), LHRH agonist/antagonist (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05999968?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial