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CYCLONE 3; NCT05288166
CDK4 & 6 Inhibitor
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*
Key Inclusion Criteria
- Adenocarcinoma of the prostate
- High-risk metastatic disease defined as ≥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
Key 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
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.