Abiraterone + Prednisone +/- Abemaciclib for Prostate Cancer
(CYCLONE 2 Trial)

Recruiting in Palo Alto (17 mi)

+198 other locations

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Eli Lilly and Company

Prior Safety Data

Breakthrough Therapy

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.

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 a stomach or intestine problem that makes it hard for me to absorb medicine or swallow big pills.

I have been treated with CYP17 inhibitors before.

I do not have serious heart or liver disease.

Participant Groups

The 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.

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: