A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
Phase 2/3 – combined trial
Conditions:
Prostate Cancer
Sponsor: Eli Lilly and Company
trial.available_in:
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Overview
This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
Who can participate
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate.
* Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI).
* Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following:
* PSA progression
* Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression
* Have adequate organ function.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Exclusion Criteria:
* Prior therapy with cytochrome P450 (CYP)17 inhibitors.
* Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 \& 6 inhibitors.
* Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer \[mHSPC\] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions.
* Currently enrolled in a clinical study involving an investigational product.
* Gastrointestinal disorder affecting the absorption or ability to swallow large pills.
* Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).
Interventions
Abemaciclib
DRUG
Placebo
DRUG
Abiraterone acetate
DRUG
Prednisone
DRUG
Locations
112
Australia (6)
Chris O'Brien Lifehouse
Camperdown , New South Wales
Southside Cancer Care Centre
Kogarah , New South Wales
Macquarie University
Macquarie University , New South Wales
Peter MacCallum Cancer Centre
Melbourne , Victoria
St Vincent's Hospital
Melbourne , Victoria
Prince of Wales Hospital
Randwick , New South Wales
China (26)
Jilin Province People's Hospital
Changchun , Jilin
Hunan Provincial People's Hospital
Changsha , Hunan
Hunan Cancer Hospital
Changsha , Hunan
Sun Yat-Sen University Cancer Centre
Guangzhou , Guangdong
The First Affiliated Hospital, Zhejiang University
Hangzhou , Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou , Zhejiang
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
Second Affiliated hospital of Anhui Medical University
Hefei , Anhui
Lanzhou university second hospital
Lanzhou , Gansu
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang , Henan
The First Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Nanchong Central Hospital
Nanchong , Sichuan
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing
Nanjing , Jiangsu
Nantong Tumor Hospital
Nantong , Jiangsu
Ningbo First Hospital
Ningbo , Zhejiang
Fudan University Shanghai Cancer Center
Shanghai , Shanghai Municipality
Huashan Hospital Affiliated Fudan University
Shanghai , Shanghai Municipality
Tianjin Medical University Cancer Institute and Hospital
Tianjin , Tianjin Municipality
The Second Hospital of Tianjin Medical University
Tianjin , Tianjin Municipality
Xinjiang Medical University Cancer Hospital - Urumqi