Darolutamide + Abemaciclib for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a combination of two oral drugs, abemaciclib and darolutamide, with hormone therapy to treat advanced prostate cancer. It aims to find the safest and most effective dose. The study focuses on men with advanced or high-risk prostate cancer. The treatment works by blocking proteins that help cancer grow and reducing hormone levels that fuel the cancer.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot take certain drugs that strongly interact with the study drugs. If you are on such medications, they must be stopped or switched at least 5 half-lives before starting the trial. It's important to discuss your current medications with the study team.
Is the combination of Darolutamide and Abemaciclib safe for humans?
Darolutamide has been shown to be generally well tolerated in men with non-metastatic castration-resistant prostate cancer, with a low risk of side effects related to the central nervous system (brain and spinal cord). However, long-term safety data from real-world use is still needed to fully understand its safety profile.12345
What makes the drug combination of Darolutamide and Abemaciclib unique for prostate cancer?
The combination of Darolutamide and Abemaciclib is unique because Darolutamide is a novel androgen receptor antagonist that effectively delays metastasis in non-metastatic castration-resistant prostate cancer, while Abemaciclib is a CDK4/6 inhibitor that targets cell cycle progression, potentially offering a complementary mechanism of action to enhance treatment efficacy.13678
What data supports the effectiveness of the drug combination Darolutamide and Abemaciclib for prostate cancer?
Darolutamide has shown positive results in delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer, as demonstrated in the phase III ARAMIS trial. Additionally, darolutamide has demonstrated antitumor activity and significant decreases in prostate-specific antigen in patients with metastatic castration-resistant prostate cancer in phase I/II trials.367910
Who Is on the Research Team?
Praful Ravi, MB BChir, MRCP
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Men over 18 with confirmed prostate adenocarcinoma, able to swallow pills and follow study rules. They must have a recent biopsy showing significant cancer presence without certain variants, no metastatic disease by specific scans, be candidates for surgical removal of the prostate, and have proper organ function. Contraception is required during and after the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Participants receive abemaciclib in combination with darolutamide and ADT at different dosages to determine the maximum tolerated dose
Phase 2 Treatment
Participants are randomized to receive either abemaciclib, darolutamide, and ADT or darolutamide and ADT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
- Darolutamide
- Goserelin
- Leuprolide Acetate
Abemaciclib is already approved in United States, European Union for the following indications:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Praful Ravi
Lead Sponsor
Praful Ravi, MB BCHir, MRCP
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD