Abiraterone + Prednisone +/- Abemaciclib for Prostate Cancer
(CYCLONE 2 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
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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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib or placebo in combination with abiraterone acetate and prednisone on a continuous dosing schedule until progression or discontinuation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib
- Abiraterone Acetate
- Prednisone
Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer
- Metastatic high-risk castration-sensitive prostate cancer
- Metastatic castration-resistant prostate cancer
- Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer
- Metastatic castration-resistant prostate cancer
- Metastatic castration-sensitive prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead 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