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

March 2, 2026 updated by: Eli Lilly and Company

A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
    • Baden-Wurttemberg
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Studienpraxis Urologie
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitatsklinikum Schleswig-Holstein
  • Spain
      • Badajoz, Spain, 06006
        • Hospital Infanta Cristina
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
    • Catalunya [Cataluña]
      • L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 8907
        • Instituto Catalan de Oncologia - Hospital Duran I Reynals
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Hospital General Universitario Gregorio Marañón
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • New York
      • Mineola, New York, United States, 11501
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.

  • Metastatic castration-resistant prostate cancer evidenced by:

    • Prostate-specific antigen (PSA) or radiographic progression despite castrate levels of testosterone
    • At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (CT/MRI)
  • Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study.
  • Have adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion Criteria:

  • Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or darolutamide.
  • Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals.
  • Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
  • Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (New York Heart Association Class III or IV) within 6 months of assignment to treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abemaciclib + Darolutamide
Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.
Drug: Abemaciclib
Administered orally.
Other Names:
  • LY2835219
Drug: Darolutamide
Administered orally.
Drug: LHRH agonist/antagonist
Physician's choice. Administered in accordance with the prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Date of first dose to study completion (approximately 32 months)
Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
Date of first dose to study completion (approximately 32 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator
Time Frame: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
rPFS Assessed by Investigator
Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Time Frame: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
ORR: Percentage of Participants with Soft Tissue BOR of CR or PR
Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
Duration of Response (DoR)
Time Frame: Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)
DOR
Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)
Time to Prostate Specific Antigen (PSA) Progression
Time Frame: Date of first dose to the first observation of PSA progression (approximately 32 months)
Time to PSA progression
Date of first dose to the first observation of PSA progression (approximately 32 months)
Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline
Time Frame: Date of first dose to confirmed PSA progression (approximately 32 months)
PSA-RR
Date of first dose to confirmed PSA progression (approximately 32 months)
Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)
Time Frame: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)
Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite
Time Frame: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
PK: Mean Concentrations of Darolutamide and its Active Metabolite
Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Bayer

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Actual)

February 23, 2024

Study Completion (Actual)

January 21, 2026

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18714
  • I3Y-MC-JPEI (Other Identifier: Eli Lilly and Company)
  • 2023-503919-15-00 (Other Identifier: EU Trial Number)
  • U1111-1294-1466 (Registry Identifier: WHO Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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