Abemaciclib + Hormone Therapy for Prostate Cancer

(RAD 1805 Trial)

Overseen By Andrew McDonald, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Must be taking: Androgen deprivation therapy

Must not be taking: CDK4-6 inhibitors

Disqualifiers: Cardiovascular disease, Hepatitis, AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

9 Participants Needed

Trial Summary

What is the purpose of this trial?

This Phase II study is designed to study the clinical and radiologic response, as well as, safety and tolerability of abemaciclib in combination with androgen deprivation therapy (ADT) in patients with localized high-risk or locally advanced prostate cancer who are eligible for definitive radiation therapy (RT) and androgen deprivation therapy (ADT).

Research Team

Andrew McDonald, MD

Principal Investigator

University of Alabama at Birmingham (UAB)

Eligibility Criteria

Men with high-risk or advanced prostate cancer that hasn't spread, who haven't had systemic anti-cancer treatments. They must have a certain level of health, including normal organ function and blood counts, be able to perform daily activities with ease or some difficulty (ECOG PS=0 or 1), and agree to use contraception.

Inclusion Criteria

Adequate hematologic and end-organ function: ANC ≥ 1500/mm3, Platelet count ≥ 100,000/mm3, Hb ≥ 9g/dl, Creatinine ≤ ULN or Creatinine Clearance (CrCl) ≥ 60 ml/min, Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert syndrome, who can have total Bilirubin > 2.0 x ULN and direct bilirubin within normal limits are permitted), AST, ALT and alkaline phosphatase ≤ ULN, Agreement to remain abstinent or use appropriate contraception, Willingness and ability to consent for self to participate in study, Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

I have at least one measurable cancer lesion.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have active hepatitis or cirrhosis.

I have an active autoimmune disease or a history of inflammatory bowel disease, and I cannot receive brachytherapy boost.

I have a cancer other than prostate cancer that doesn't need further treatment.

Treatment Details

Interventions

• Abemaciclib
• Androgen deprivation therapy (ADT)

Trial Overview The trial is testing the effectiveness and safety of abemaciclib pills taken twice daily in combination with standard hormone therapy for prostate cancer. Participants will also receive radiation therapy as part of their treatment.

Participant Groups

Group I: Abemaciclib + ADT+ RT Experimental Treatment 3 Interventions

Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT.

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

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