CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05288166Tipo: INTERVENTIONALInicio: 14 de abr de 2022Fin estimado: 1 de oct de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Adenocarcinoma of the prostate (as the predominant histology)
High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:
Greater than or equal to (≥)4 bone metastases by bone scan and/or
≥1 visceral metastases by computed tomography or magnetic resonance imaging
Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Criterios de exclusión

Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 \& 6) inhibitor
Development of metastatic prostate cancer in the context of castrate levels of testosterone
Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
Uncontrolled hypertension
Clinically active or chronic liver disease, moderate/severe hepatic impairment
Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization

Intervenciones

drug

Abemaciclib

Administered orally.

drug

Abiraterone

Administered orally.

drug

Prednisone or Prednisolone

Administered orally.

drug

Placebo for Abemaciclib

Administered orally.

Ubicaciones

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Investigaciones Clinicas Moleculares (ICM)

Buenos Aires, Buenos Aires F.D., Argentina

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Buenos Air, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Fundación Cenit Para La Investigación En Neurociencias

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Oncologico Korben

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Centro Urológico Profesor Bengió

Córdoba, Argentina

Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

San Juan, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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