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Cyclin-Dependent Kinase (CDK) Inhibitor
Abemaciclib + Darolutamide for Advanced Prostate Cancer
Phase 1
Recruiting
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
Study Summary
This trial is exploring the safety & tolerability of combining abemaciclib & darolutamide for advanced prostate cancer treatment. Participation may last 32 months.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary outcome measures
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 moreTrial 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
Abemaciclib
2019
Completed Phase 2
~1710
Darolutamide
2018
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,510 Total Patients Enrolled
15 Trials studying Prostate Cancer
2,016 Patients Enrolled for Prostate Cancer
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,704 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,142 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still open spots for enrollment in this research endeavor?
"According to the clinicaltrials.gov database, this trial is no longer accepting applicants. The initial posting was on September 1st 2024 and last update took place on August 14th 2023. At present, 1258 other studies have opened their doors for recruitment of patients."
Answered by AI
Has the combination of Abemaciclib and Darolutamide received regulatory authorization?
"Abemaciclib + Darolutamide can be considered of low safety, earning it a score of 1. This is mainly due to the limited evidence available for its efficacy and safety from Phase 1 trials."
Answered by AI
Are there numerous US-based medical centers actively conducting this research?
"The current recruitment initiative is enrolling patients from 11 distinct sites, including New york, Nürtingen and Munich. It would be beneficial to select a clinic that offers the trial closest to you in order to limit travel commitments should you take part."
Answered by AI
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