The trial is taking place at:
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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)

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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: Prednisone or Prednisolone
Drug: Abiraterone

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

900 participants in 2 patient groups

Abemaciclib + Abiraterone + Prednisone/Prednisolone
Experimental group
Description:
Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.
Treatment:
Drug: Abiraterone
Drug: Prednisone or Prednisolone
Drug: Abemaciclib
Placebo + Abiraterone + Prednisone/Prednisolone
Active Comparator group
Description:
Placebo + abiraterone + prednisone/prednisolone administered orally.
Treatment:
Drug: Abiraterone
Drug: Prednisone or Prednisolone
Drug: Placebo for Abemaciclib

Trial contacts and locations

260

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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