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Prostatic NeoplasmsPhase 1NCT05999968

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

A Phase 1 study testing Abemaciclib, Darolutamide and LHRH agonist/antagonist in people with Prostatic Neoplasms, run by Eli Lilly and Company at 13 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Abemaciclib, Darolutamide and LHRH agonist/antagonist
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
13 sitesin 3 countries
Study dates
12 Jan 2024to 21 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

Spain6 sites

  • Hospital Infanta Cristina

    Badajoz, 06006

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 8907

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Comunidad de, 28009

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Germany4 sites

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538

  • Klinikum Rechts Der Isar Der Technischen Universität München

    Munich, Bavaria, 81675

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

Other trials in Germany

United States3 sites

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

Other trials in United States

About this study

Official title: 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.

Being tested
Abemaciclib, Darolutamide, LHRH agonist/antagonist
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally.

  • DarolutamideDrug

    Administered orally.

  • LHRH agonist/antagonistDrug

    Physician's choice. Administered in accordance with the prescribing information.

Study groups in NCT05999968
Study groupRoleWhat they receive
Abemaciclib + DarolutamideExperimentalAbemaciclib 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.
Receives: Drug: Abemaciclib; Drug: Darolutamide; Drug: LHRH agonist/antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration

    Measured: Date of first dose to study completion (approximately 32 months)

Secondary outcomes (7)

  1. Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator

    rPFS Assessed by Investigator

    Measured: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)

  2. Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)

    ORR: Percentage of Participants with Soft Tissue BOR of CR or PR

    Measured: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)

  3. Duration of Response (DoR)

    DOR

    Measured: Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)

  4. Time to Prostate Specific Antigen (PSA) Progression

    Time to PSA progression

    Measured: Date of first dose to the first observation of PSA progression (approximately 32 months)

  5. Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline

    PSA-RR

    Measured: Date of first dose to confirmed PSA progression (approximately 32 months)

  6. Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)

    PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)

    Measured: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)

  7. Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite

    PK: Mean Concentrations of Darolutamide and its Active Metabolite

    Measured: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start12 Jan 2024
  3. Primary completion23 Feb 2024
  4. Study completion21 Jan 2026

Why it stopped: The study was terminated early as related study I3Y-MC-JPCM (NCT03706365) did not meet its primary endpoint.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05999968
Sponsor's protocol ID
18714
Other IDs
I3Y-MC-JPEI, 2023-503919-15-00, U1111-1294-1466, 2023
Status last verified
Jun 2026
First submitted
14 Aug 2023
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abemaciclib, Darolutamide and LHRH agonist/antagonist in people with Prostatic Neoplasms, run by Eli Lilly and Company at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain, Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated early as related study I3Y-MC-JPCM (NCT03706365) did not meet its primary endpoint.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05999968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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