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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05999968
Collaborator
(none)
50
Enrollment
15
Locations
1
Arm
30.6
Anticipated Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer
Anticipated Study Start Date :
Jan 9, 2024
Anticipated Primary Completion Date :
Jan 27, 2025
Anticipated Study Completion Date :
Jul 27, 2026

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator [Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)]

      rPFS Assessed by Investigator

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

    3. Duration of Response (DoR) [Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)]

      DOR

    4. Time to Prostate Specific Antigen (PSA) Progression [Date of first dose to the first observation of PSA progression (approximately 32 months)]

      Time to PSA progression

    5. Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline [Date of first dose to confirmed PSA progression (approximately 32 months)]

      PSA-RR

    6. Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s) [Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)]

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

    7. Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite [Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)]

      PK: Mean Concentrations of Darolutamide and its Active Metabolite

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola New York United States 11501
    2 Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola New York United States 11501
    3 Laura and Isaac Perlmutter Cancer Center New York New York United States 10016
    4 Laura and Isaac Perlmutter Cancer Center New York New York United States 10016
    5 Studienpraxis Urologie Nürtingen Baden-Württemberg Germany 72622
    6 Studienpraxis Urologie Nürtingen Baden-Württemberg Germany 72622
    7 Urologische Klinik und Poliklinik Munich Bayern Germany 81675
    8 Klinik für Urologie Lübeck Schleswig-Holstein Germany 23538
    9 Onkologisches Zentrum Hamburg Germany 20246
    10 Medical Oncology Hospitalet Barcelona [Barcelona] Spain 08907
    11 Oncology Madrid Madrid, Comunidad De Spain 28009
    12 Medical Oncology Madrid Madrid, Comunidad De Spain 28034
    13 Medical Oncology Madrid Madrid, Comunidad De Spain 28041
    14 Oncología Médica Badajoz Spain 06006
    15 Medical Oncology Sevilla Spain 41013

    Sponsors and Collaborators

    • Eli Lilly and Company

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05999968
    Other Study ID Numbers:
    • 18714
    • I3Y-MC-JPEI
    • 2023-503919-15-00
    • U1111-1294-1466
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Aug 25, 2023