9 Participants Needed

Darolutamide + Abemaciclib for Prostate Cancer

PR
Overseen ByPraful Ravi, MB BChir, MRCP
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: Praful Ravi
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

PR

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

My organs and bone marrow are working well.
Provision of signed informed consent prior to any study specific procedures, or have a legally authorized representative sign on the participant's behalf
I can take pills and follow study rules.
See 3 more

Exclusion Criteria

I have a history of cancer.
I haven't had cancer in the last 5 years, except for skin cancer.
I have other medical conditions or another active cancer.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive abemaciclib in combination with darolutamide and ADT at different dosages to determine the maximum tolerated dose

6 months
Evaluations every 12 weeks

Phase 2 Treatment

Participants are randomized to receive either abemaciclib, darolutamide, and ADT or darolutamide and ADT

6 months
PSA measured day 1 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Abemaciclib
  • Darolutamide
  • Goserelin
  • Leuprolide Acetate
Trial Overview The trial tests combining two oral drugs (abemaciclib and darolutamide) with standard hormone therapy for various stages of prostate cancer. The first phase will determine safe dosages before expanding into broader testing. About 93 participants will undergo treatment for six months followed by up to four-and-a-half years of monitoring.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Phase 2 - Neoadjuvant Darolutamide, Ademaciclib, and ADT prior to Radical ProstatectomyExperimental Treatment5 Interventions
per protocol, for 6, 28-day cycles
Group II: Phase 2 - Neoadjuvant Darolutamide and ADT prior to Radical ProstatectomyExperimental Treatment4 Interventions
per protocol, for 6, 28-day cycles
Group III: Phase 1 Lead In in CRPCExperimental Treatment5 Interventions
Standard 3+3 dose escalation scheme with 3 dose levels of abemaciclib and a constant dose of darolutamide, per protocol, for 6, 28-day cycles

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:
  • 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

Trials
1
Recruited
9+

Praful Ravi, MB BCHir, MRCP

Lead Sponsor

Trials
1
Recruited
9+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Bayer

Industry Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

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 profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

Darolutamide (NUBEQA™) is a new non-steroidal androgen receptor antagonist approved for treating non-metastatic castration-resistant prostate cancer in men, based on positive results from the phase III ARAMIS trial.
The approval of darolutamide marks a significant milestone in prostate cancer treatment, highlighting its efficacy and safety profile as demonstrated in clinical trials.
Darolutamide: First Approval.Markham, A., Duggan, S.[2020]
In a study involving 249 men with metastatic castrate-resistant prostate cancer, patient preference between darolutamide and enzalutamide was balanced, with no significant preference for either treatment (p = 0.92).
Darolutamide was associated with less fatigue and a moderate improvement in episodic memory compared to enzalutamide, suggesting it may offer a better quality of life for patients.
A Randomized, Open-label, Cross-over Phase 2 Trial of Darolutamide and Enzalutamide in Men with Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer: Patient Preference and Cognitive Function in ODENZA.Colomba, E., Jonas, SF., Eymard, JC., et al.[2023]
In a phase 3 trial involving 1509 men with nonmetastatic, castration-resistant prostate cancer, darolutamide significantly improved metastasis-free survival, with a median of 40.4 months compared to 18.4 months for placebo (hazard ratio 0.41).
The safety profile of darolutamide was comparable to placebo, with similar rates of adverse events and no increased risk of serious side effects like seizures or cognitive disorders.
Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer.Fizazi, K., Shore, N., Tammela, TL., et al.[2022]

Citations

Darolutamide: First Approval. [2020]
A Randomized, Open-label, Cross-over Phase 2 Trial of Darolutamide and Enzalutamide in Men with Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer: Patient Preference and Cognitive Function in ODENZA. [2023]
Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. [2022]
Clinical Development of Darolutamide: A Novel Androgen Receptor Antagonist for the Treatment of Prostate Cancer. [2019]
5.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Treatment of Metastatic, Castration-resistant, Docetaxel-resistant Prostate Cancer: A Systematic Review of Literature With a Network Meta-analysis of Randomized Clinical Trials. [2021]
Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer. [2022]
Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. [2022]
Higher Risk of Fragility Fractures in Prostate Cancer Patients Treated with Combined Radium-223 and Abiraterone: Prednisone May Be the Culprit. [2022]
A real-world evaluation of radium-223 in combination with abiraterone or enzalutamide for the treatment of metastatic castration-resistant prostate cancer. [2021]
Darolutamide: A Review in Metastatic Hormone-Sensitive Prostate Cancer. [2023]
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