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Cyclin-Dependent Kinase (CDK) Inhibitor
Abemaciclib + Darolutamide for Advanced Prostate Cancer
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of first dose to study completion (approximately 32 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of two drugs, abemaciclib and darolutamide, in men whose prostate cancer has spread after initial treatment. The study aims to see if these drugs can be safely used together. Darolutamide is a new drug approved for treating a specific type of prostate cancer and has shown effectiveness in delaying the spread of the disease.
Who is the study for?
Men with prostate cancer that has spread after initial treatment can join this trial. They should be relatively healthy (ECOG PS 0-1), have not had certain prior treatments like CDK4/6 inhibitors or darolutamide, and must continue hormone therapy if they haven't had their testicles removed. No recent severe heart problems allowed.
What is being tested?
The study is testing the safety of combining two drugs, Abemaciclib and Darolutamide, in men whose prostate cancer has worsened despite low testosterone levels. Participants will also receive LHRH agonists/antagonists if needed for up to almost three years.
What are the potential side effects?
Possible side effects include fatigue, digestive issues, blood cell changes leading to increased infection risk or bleeding problems, liver function changes, and potential heart complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of first dose to study completion (approximately 32 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of first dose to study completion (approximately 32 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary study objectives
Duration of Response (DoR)
Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Abemaciclib + DarolutamideExperimental Treatment3 Interventions
Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide
2018
Completed Phase 2
~100
Abemaciclib
2019
Completed Phase 2
~1890
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often target the mechanisms that drive cancer cell growth. CDK4/6 inhibitors, such as Abemaciclib, work by blocking cyclin-dependent kinases 4 and 6, which are crucial for cell cycle progression.
This inhibition prevents cancer cells from proliferating. Androgen receptor inhibitors, like Darolutamide, block the androgen receptor signaling pathway, which is essential for the growth and survival of prostate cancer cells.
By inhibiting this pathway, these drugs reduce the cancer cells' ability to thrive. These mechanisms are vital for prostate cancer patients as they directly target the processes that allow cancer cells to grow and spread, potentially improving outcomes and survival rates.
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Who is running the clinical trial?
BayerIndustry Sponsor
2,275 Previous Clinical Trials
25,539,389 Total Patients Enrolled
45 Trials studying Prostate Cancer
26,975 Patients Enrolled for Prostate Cancer
Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,973 Total Patients Enrolled
17 Trials studying Prostate Cancer
2,297 Patients Enrolled for Prostate Cancer
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,368 Total Patients Enrolled
8 Trials studying Prostate Cancer
1,645 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well.My prostate cancer was confirmed through a tissue examination.I have not had serious heart problems like a heart attack or heart failure in the last 6 months.I have had treatments like chemotherapy or hormone therapy for advanced prostate cancer.My prostate cancer has spread, is resistant to hormone therapy, and shows on scans.I have been treated with CDK4/6 inhibitors or darolutamide.I am fully active or can carry out light work.I have not had both testicles removed and will continue hormone therapy during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib + Darolutamide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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