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 resistantprostate cancer.
Participant must have diagnosis of prostate cancer that is metastatic
Participant must have prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant)
Participant must have documented evidence of progressive disease by imaging and/or PSA test
Participant must be willing to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research
Participant must not have received any of the following prior therapies: abiraterone acetate, abemaciclib, chemotherapy in the castration-resistant setting, radiopharmaceuticals, enzalutamide, apalutamide, darolutamide or sipuleucel-T
Participants must not have conditions that are not compatible with the clinical trial participation such as inability to swallow large pills, active or chronic liver disease, clinically significant heart disease, HIV, AIDS, active or uncontrolled clinically serious infection, or uncontrolled hypertension
Participant must not have brain metastases
Participant of reproductive potential must not father a child and must agree to use medically approved contraceptive precautions, and not donate sperm, during the study and for three months following the last dose of study drug
By volunteering to take part in Prostate cancer clinical trials, you may be able to play an important role in the research and development of potential new treatments and medicines. We understand that when you or a loved one take part in a clinical trial, it is a big decision. It is important for you to understand why the research is being carried out and what taking part will mean for you. Learn more about Lilly
Prostate Cancer Research
Lilly has been involved in cancer research for more than fifty years, working to improve the lives of people living with cancer. Learn more about cancer research at Lilly and how you can make an impact.
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A clinical trial is a scientific study. It helps us learn if a new medicine or treatment works and how it works. Clinical trials can also be called clinical research studies. Learn more about clinical research studies and what to expect when taking part in a clinical trial.