Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
NCT ID: NCT05999968
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2024-01-12
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Abemaciclib
Administered orally.
Darolutamide
Administered orally.
LHRH agonist/antagonist
Physician's choice. Administered in accordance with the prescribing information.
Interventions
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Abemaciclib
Administered orally.
Darolutamide
Administered orally.
LHRH agonist/antagonist
Physician's choice. Administered in accordance with the prescribing information.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Highlands Oncology Group
Springdale, Arkansas, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany
Klinikum Rechts Der Isar Der Technischen Universität München
Munich, Bavaria, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Instituto Catalan de Oncologia - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Infanta Cristina
Badajoz, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Countries
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Related Links
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Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
Other Identifiers
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I3Y-MC-JPEI
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503919-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1294-1466
Identifier Type: REGISTRY
Identifier Source: secondary_id
18714
Identifier Type: -
Identifier Source: org_study_id
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