NCT03706365|Active Not RecruitingPhase 2ResultsDMCFDA Drug

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

CYCLONE 2

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

Eli Lilly and Company ClinicalTrials.gov

Compare

4 other identifiers

16598I3Y-MC-JPCM2016-004276-212023-506777-36-00

Study Type

interventional

Target

393

Locations

11 countries

Sites

112

Timeline

RegisteredOct 2018

StartedNov 2018

CompletionJun 2026

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Strong global presence with extensive site network

Enrollment

393

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline

Completed

Started Nov 2018

Longer than P75 for phase_2 prostate-cancer

Geographic Reach

11 countries

112 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.5 years study duration

First Submitted

Initial submission to the registry

September 18, 2018

Completed

28 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed

1 month until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 6, 2025

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

September 18, 2018

Results QC Date

December 31, 2024

Last Update Submit

April 7, 2026

Conditions

Prostate Cancer

Keywords

Metastatic Castration Resistant Prostate CancermCRPC

Outcome Measures

Primary Outcomes (1)

Radiographic Progression Free Survival (rPFS)
The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.
From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

Secondary Outcomes (11)

Time to Prostate-Specific Antigen (PSA) Progression
From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)
Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review
From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Baseline to Radiographic Disease Progression (Up to 60 Months)
Duration of Response (DOR)
Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
Overall Survival (OS)
From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)
+6 more secondary outcomes

Study Arms (2)

Abemaciclib

EXPERIMENTAL

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.

Drug: AbemaciclibDrug: Abiraterone acetateDrug: Prednisone

Placebo

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Abiraterone acetateDrug: Prednisone

Interventions

AbemaciclibDRUG

Administered orally.

Also known as: LY2835219

Abemaciclib

PlaceboDRUG

Administered orally.

Placebo

Abiraterone acetateDRUG

Administered orally.

AbemaciclibPlacebo

PrednisoneDRUG

Administered orally.

AbemaciclibPlacebo

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed adenocarcinoma of the prostate.
Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI).
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.

You may not qualify if:

Prior therapy with cytochrome P450 (CYP)17 inhibitors.
Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 \& 6 inhibitors.
Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer \[mHSPC\] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions.
Currently enrolled in a clinical study involving an investigational product.
Gastrointestinal disorder affecting the absorption or ability to swallow large pills.
Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (112)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85004, United States

Location

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, 85054, United States

Location

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, 85719, United States

Location

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

CBCC Global Research, Inc.

Bakersfield, California, 93309, United States

Location

Providence St. Jude Medical Center

Fullerton, California, 92835, United States

Location

Moores Cancer Center

La Jolla, California, 92093, United States

Location

TRIO-US (Translational Research in Oncology-US)

Los Angeles, California, 90024, United States

Location

UCLA Hematology/Oncology - Westwood (Building 100)

Los Angeles, California, 90095, United States

Location

Pacific Cancer Care

Monterey, California, 93940, United States

Location

Sansum Clinic_Kendle

Santa Barbara, California, 93105, United States

Location

Rocky Mountain Cancer Center

Lone Tree, Colorado, 80124, United States

Location

Millennium Oncology - Hollywood

Hollywood, Florida, 33024, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center

Fort Wayne, Indiana, 46804, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, 55455, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89119, United States

Location

New York Oncology Hematology (NYOH) - Clifton Park Cancer Center

Albany, New York, 12206, United States

Location

Associated Medical Professionals - Urology

Syracuse, New York, 13210, United States

Location

Research Medical Center

Nashville, Tennessee, 37203, United States

Location

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

Location

New York Oncology Hematology (NYOH) - Clifton Park Cancer Center