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)

• Status: Not yet recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Prednisolone; Prednisone

Criteria

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