What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as CDK4/6 inhibitors (e.g., Abemaciclib) and androgen receptor inhibitors (e.g., Darolutamide), have distinct side effect profiles. CDK4/6 inhibitors often cause neutropenia, diarrhea, and increased creatinine levels. Androgen receptor inhibitors like Darolutamide are generally better tolerated but can lead to fatigue, hypertension, and gastrointestinal issues. These side effects should be carefully monitored and managed in clinical practice.

What prior FDA approvals exist?

For the treatment of prostate cancer, several androgen receptor inhibitors have been approved by the FDA. These include enzalutamide, apalutamide, and darolutamide, which block the androgen receptor signaling pathway to inhibit cancer growth. Darolutamide, in particular, is noted for its lower risk of central nervous system side effects due to its distinct structure. While abemaciclib, a CDK4/6 inhibitor, is primarily approved for breast cancer, its combination with other agents like darolutamide is being explored in clinical trials for prostate cancer. These treatments aim to improve outcomes by targeting specific pathways involved in cancer cell proliferation and survival.

What other types of research exist?

Promising novel alternatives to Abemaciclib and Darolutamide for prostate cancer patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown activity in metastatic castration-resistant prostate cancer (mCRPC) in studies like KEYNOTE-199. 2) Atezolizumab, another immune checkpoint inhibitor, evaluated in combination with enzalutamide in mCRPC. 3) Olaparib, a PARP inhibitor, particularly effective in patients with homologous recombination repair (HRR) gene mutations, as demonstrated in the BRCAAWAY trial. 4) Lutetium-177-PSMA-617, a radioligand therapy, which has shown promise in the VISION trial for PSMA-positive mCRPC.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of first dose to study completion (approximately 32 months) for reporting.

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 more

Awards & 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

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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.