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

Stopped early · Phase 1

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT05999968

Run by

Eli Lilly and Company

People needed

10

Starts

2024-01-12

Expected to finish

2026-01-21

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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