A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Cytochrome P-450; Antineoplastic Agents, Hormonal; Physiological Effects of Drugs; Antineoplastic Agents; Prednisone; Cyclin-Dependent Kinase 6; Enzyme Inhibitors; Neoplasm Metastasis; Prednisolone; Abiraterone Acetate; Hormones, Hormone Substitutes, and Hormone Antagonists; Steroid Synthesis Inhibitors; Hormones; Urogenital Neoplasms; Androgens; Prostatic Neoplasms; Cyclin-Dependent Kinase 4

Treatments: Drug: Placebo for Abemaciclib; Drug: Abemaciclib; Drug: Abiraterone; Drug: Prednisone or Prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05288166

I3Y-MC-JPEG (Other Identifier)

18448

2022-500461-28-06 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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900 participants in 2 patient groups

Abemaciclib + Abiraterone + Prednisone/Prednisolone

Experimental group

Description:

Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.

Treatment:

Drug: Prednisone or Prednisolone

Drug: Abiraterone

Drug: Abemaciclib

Placebo + Abiraterone + Prednisone/Prednisolone

Active Comparator group

Description:

Placebo + abiraterone + prednisone/prednisolone administered orally.

Treatment:

Drug: Prednisone or Prednisolone

Drug: Abiraterone

Drug: Placebo for Abemaciclib