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 (CYCLONE 3)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2027
  • participants needed
    900
  • sponsor
    Eli Lilly and Company
Updated on 16 September 2022
cancer
bone metastases
adenocarcinoma

Summary

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.

Details
Condition Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs, Antineoplastic Agents, Antineoplastic Agents, Hormonal, Androgens, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Abiraterone Acetate, Steroid Synthesis Inhibitors, Cytochrome P-450, Enzyme Inhibitors, Prednisone, Prednisolone, Cyclin-Dependent Kinase 4, Cyclin-Dependent Kinase 6
Treatment Abiraterone, Abemaciclib, Prednisone or Prednisolone, Placebo for Abemaciclib
Clinical Study IdentifierNCT05288166
SponsorEli Lilly and Company
Last Modified on16 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adenocarcinoma of the prostate
High-risk metastatic disease defined as
Greater than or equal to (≥)4 bone metastases and/or
≥1 visceral metastases
Androgen deprivation therapy (either medical with a luteinizing hormone-releasing
hormone [LHRH] analogue or surgical castration) must have been started prior
to randomization and continued throughout the study
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 (≤50 ng/dL)
Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), the following exceptions are permitted
Up to 3 months of androgen deprivation therapy (ADT) (when given without docetaxel) AND absence of radiographic or prostate specific antigen (PSA) progression prior to randomization
Up to 6 cycles of docetaxel with ADT AND absence of radiographic or PSA progression prior to randomization
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. Patients with a history of treated brain metastases are eligible provided that disease is stable following treatment for at least 8 weeks prior to randomization and no requirement for corticosteroid use
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