Abemaciclib + Darolutamide for Advanced Prostate Cancer

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My organs are working well.

My prostate cancer was confirmed through a tissue examination.

My prostate cancer has spread, is resistant to hormone therapy, and shows on scans.

+2 more

Exclusion Criteria

Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study

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.

+1 more

Participant Groups

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.

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.

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: