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

NCT05999968 | Completed Phase 1 FDA Drug

• 4 other identifiers: 18714I3Y-MC-JPEI2023-503919-15-00U1111-1294-1466
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 13

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (7)

• 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)

• 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)

• Duration of Response (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

  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

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

Study Arms (1)

Abemaciclib + Darolutamide

EXPERIMENTAL

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; Drug: Darolutamide; Drug: LHRH agonist/antagonist

Interventions

LHRH agonist/antagonist DRUG

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

Abemaciclib + Darolutamide

Abemaciclib DRUG

Administered orally.

Also known as: LY2835219

Abemaciclib + Darolutamide

Darolutamide DRUG

Administered orally.

Abemaciclib + Darolutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Bayer: collaborator

Study Sites (13)

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Studienpraxis Urologie

Nürtingen, Baden-Wurttemberg, 72622, Germany

Location

Klinikum Rechts Der Isar Der Technischen Universität München

Munich, Bavaria, 81675, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Instituto Catalan de Oncologia - Hospital Duran i Reynals

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

Location

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Comunidad de, 28009, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Infanta Cristina

Badajoz, 06006, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abemaciclib; darolutamide; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: January 12, 2024
• Primary Completion: February 23, 2024
• Study Completion: January 21, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); US (3); DE (4)