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)
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.
Who can participate
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
Locations
24
Argentina (1)
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata , Buenos Aires
Australia (1)
Chris O'Brien Lifehouse
Camperdown , New South Wales
Belgium (1)
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst , Oost-Vlaanderen
Brazil (1)
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza , Ceará
Canada (1)
Sunnybrook Health Sciences Centre
Toronto , Ontario
China (1)
Afflilated Hospital of Bengbu Medical College
Bengbu , Anhui
Czech Republic (1)
Nemocnice Horovice
Hořovice , Beroun
France (1)
Centre Leon Berard
Lyon , Auvergne-Rhône-Alpes
Germany (1)
Universitaetsklinikum Freiburg
Freiburg im Breisgau , Baden-Wurttemberg
Greece (1)
University Hospital of Patras
Pátrai , Achaḯa
Hungary (1)
Bacs-Kiskun Megyei Korhaz
Kecskemét , Bács-Kiskun county
Israel (1)
Meir Medical Center
Kfar Saba , Central District
Italy (1)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , Emilia-Romagna
Japan (1)
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya , Aichi-ken
Mexico (1)
Actualidad Basada en la Investigación del Cáncer
Guadalajara , Jalisco
Netherlands (1)
ETZ Elisabeth
Tilburg , North Brabant
Poland (1)
Clinical Best Solutions
Lublin , Lublin Voivodeship
Romania (1)
C.M.D.T.A. Neomed
Brasov , Brașov County
South Korea (1)
Seoul National University Hospital
Seoul , Seoul-teukbyeolsi [Seoul]
Spain (1)
Instituto Catalan de Oncologia - Hospital Duran i Reynals