393 Participants Needed

Abiraterone + Prednisone +/- Abemaciclib for Prostate Cancer

(CYCLONE 2 Trial)

Recruiting at 198 trial locations
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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Male
Trial Phase: Phase 2 & 3
Sponsor: Eli Lilly and Company
Must be taking: Abiraterone, Prednisone
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had prior treatment with certain prostate cancer drugs or be currently enrolled in another clinical study.

What data supports the effectiveness of the drug combination Abiraterone, Prednisone, and Abemaciclib for prostate cancer?

Research shows that Abiraterone acetate combined with Prednisone significantly improves survival in patients with metastatic castration-resistant prostate cancer. While specific data on Abemaciclib in this combination is not provided, Abiraterone and Prednisone have proven benefits in similar patient groups.12345

Is the combination of Abiraterone and Prednisone safe for treating prostate cancer?

The combination of Abiraterone (Zytiga) and Prednisone is generally considered safe for treating metastatic castration-resistant prostate cancer, though it can cause side effects like low potassium levels, high blood pressure, fluid retention, and liver issues. These side effects were relatively low in frequency in clinical trials.12678

What makes the drug combination of Abiraterone, Prednisone, and Abemaciclib unique for prostate cancer?

This treatment is unique because it combines Abiraterone, which blocks the production of male hormones that fuel prostate cancer, with Prednisone, a steroid that helps manage side effects, and potentially adds Abemaciclib, a drug that targets cancer cell growth, offering a novel approach to treating prostate cancer.1291011

Research Team

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Men with advanced prostate cancer that has spread and is resistant to hormone therapy can join. They must have a specific type of prostate cancer confirmed by tests, worsening disease despite ongoing hormone treatment, and their body should be functioning well enough (ECOG 0-1). Men who've had certain other treatments or have serious heart, liver, or digestive problems cannot participate.

Inclusion Criteria

Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following: PSA progression, Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression, Have adequate organ function, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
My prostate cancer has spread, confirmed by a bone scan or CT/MRI.
My prostate cancer is confirmed by tissue analysis.

Exclusion Criteria

I have not taken abemaciclib or any CDK 4 & 6 inhibitors before.
I have had chemotherapy or specific treatments for advanced prostate cancer, but not for all cancer spots.
I have a stomach or intestine problem that makes it hard for me to absorb medicine or swallow big pills.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abemaciclib or placebo in combination with abiraterone acetate and prednisone on a continuous dosing schedule until progression or discontinuation

Up to 60 months
Continuous dosing on a 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

Treatment Details

Interventions

  • Abemaciclib
  • Abiraterone Acetate
  • Prednisone
Trial OverviewThe trial is testing the safety and effectiveness of adding abemaciclib to the standard treatment for this stage of prostate cancer: abiraterone acetate plus prednisone. Some participants will receive a placebo instead of abemaciclib to compare outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AbemaciclibExperimental Treatment3 Interventions
Participants received 200 milligrams (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
Group II: PlaceboPlacebo Group3 Interventions
Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Zytiga for:
  • Metastatic castration-resistant prostate cancer
  • Metastatic high-risk castration-sensitive prostate cancer
🇪🇺
Approved in European Union as Zytiga for:
  • Metastatic castration-resistant prostate cancer
  • Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer
🇨🇦
Approved in Canada as Zytiga for:
  • Metastatic castration-resistant prostate cancer
  • Metastatic castration-sensitive prostate cancer
🇯🇵
Approved in Japan as Zytiga for:
  • Prostate cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead 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

Findings from Research

Oral abiraterone acetate (Zytiga®) significantly improves overall survival and progression-free survival in patients with metastatic castration-resistant prostate cancer (CRPC) when used with prednisone, compared to a placebo.
The treatment is specifically effective for patients who have already undergone docetaxel-containing chemotherapy, highlighting its role as a subsequent therapy in advanced prostate cancer management.
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer.Scott, LJ., Yang, LPH., Lyseng-Williamson, KA.[2021]
In a phase 3 trial involving 1199 patients, the addition of abiraterone acetate and prednisone to androgen-deprivation therapy significantly improved overall survival, with a median survival not reached in the abiraterone group compared to 34.7 months in the placebo group.
The study also showed that patients receiving abiraterone had a median radiographic progression-free survival of 33.0 months, compared to 14.8 months in the placebo group, indicating a strong benefit in delaying disease progression.
Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer.Fizazi, K., Tran, N., Fein, L., et al.[2022]
In a multicenter early-access trial involving 2314 patients with metastatic castration-resistant prostate cancer, abiraterone acetate combined with prednisone showed a median time to PSA progression of 8.5 months and a median time to clinical progression of 12.7 months, indicating its efficacy in delaying disease progression after chemotherapy.
The study reported that 41% of patients experienced grade 3 or 4 treatment-related adverse events, with hepatotoxicity and hypertension being the most common, but no new safety signals were identified, suggesting that abiraterone acetate is generally safe for use in this patient population.
Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial.Sternberg, CN., Castellano, D., Daugaard, G., et al.[2022]

References

Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer. [2021]
Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. [2022]
Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study. [2022]
Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. [2022]
High-Dose Abiraterone Acetate in Men With Castration Resistant Prostate Cancer. [2018]
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary. [2018]
Abiraterone acetate: a review of its use in patients with metastatic castration-resistant prostate cancer. [2021]
Abiraterone acetate to treat metastatic castration-resistant prostate cancer in combination with prednisone. [2020]
Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Assessment of the Safety of Glucocorticoid Regimens in Combination With Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer: A Randomized, Open-label Phase 2 Study. [2022]
Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. [2022]