Prostatic Neoplasms
Conditions
Interventions
-Drug: Abemaciclib
Administered orally.
Other Name: LY2835219
-Drug: Abiraterone
Administered orally.
-Drug: Prednisone or Prednisolone
Administered orally.
-Drug: Placebo for Abemacic
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
Male
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Progression-Free Survival (rPFS) Assessed by Investigator [ Time Frame: Randomization to radiographic progression or death from any cause (approximately 48 months) ] rPFS Assessed by Investigator | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed