A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer (CYCLONE 2)

April 7, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
393

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Kogarah, New South Wales, Australia, 2228
        • Southside Cancer Care Centre
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Second Affiliated hospital of Anhui Medical University
      • Wuhu, Anhui, China, 241001
        • Wannan Medical College Yijishan Hospital
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Lanzhou University Second Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Centre
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical,Science & Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing
      • Nantong, Jiangsu, China, 226361
        • Nantong Tumor Hospital
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • Jilin Province People's Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Yantai, Shandong, China, 264099
        • Yantai Yuhuangding Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital Affiliated Fudan University
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Nanchong Central Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, China, 300211
        • The Second Hospital of Tianjin Medical University
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Xinjiang Medical University Cancer Hospital - Urumqi
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Rigshospitalet
    • Region Sjælland
      • Næstved, Region Sjælland, Denmark, 4700
        • Næstved Sygehus
  • France
      • Bordeaux, France, 33075
        • CHU de Bordeaux Hop St ANDRE
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69373
        • Centre léon bérard
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34070
        • Centre de Cancerologie du Grand Montpellier
    • Pays de la Loire Region
      • Le Mans, Pays de la Loire Region, France, 72000
        • Clinique Victor Hugo Le Mans
    • Vendée
      • La Roche-sur-Yon, Vendée, France, 85000
        • CHD Vendee
    • Île-de-France Region
      • Créteil, Île-de-France Region, France
        • Henri Mondor Hospital
  • Germany
    • Baden-Wurttemberg
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Studienpraxis Urologie
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen
    • Lower Saxony
      • Holzminden, Lower Saxony, Germany, 37603
        • Gesundheitszentrum Holzminden
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50968
        • Studienzentrum Bayenthal Urologische Partnerschaft Köln
      • Mettmann, North Rhine-Westphalia, Germany, 40822
        • Urologie Neandertal - Praxis Mettmann
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitätsklinikum Münster - Albert Schweitzer Campus
      • Wesel, North Rhine-Westphalia, Germany, 46483
        • Private Practice - Dr. Stammel & Dr. Garcia
    • Saxony
      • Leipzig, Saxony, Germany, 4105
        • Private Practice - Dr. Silvio Szymula
    • Saxony-Anhalt
      • Eisleben Lutherstadt, Saxony-Anhalt, Germany, 06295
        • Private Practice - Dr. Ralf Eckert
  • Japan
      • Gifu, Japan, 501-1112
        • Gifu University Hospital
      • Kumamoto, Japan, 860-0008
        • National Hospital Organization Kumamoto Medical Center
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8650
        • Japanese Red Cross Nagoya Daini Hospital
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Hirosaki University Hospital
    • Chiba
      • Sakura, Chiba, Japan, 285-0841
        • Toho University Sakura Medical Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
    • Saitama
      • Ina-machi, Saitama, Japan, 362-0806
        • Saitama Prefectural Cancer Center
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital
    • Tokyo
      • Shinagawa, Tokyo, Japan, 142-8555
        • Showa University Hospital
  • Netherlands
      • Utrecht, Netherlands, 3543 AZ
        • St. Antonius Ziekenhuis, locatie Utrecht
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
  • Romania
      • Bucharest, Romania, 31422
        • Gral Medical Diagnostic Center
    • Constanța County
      • Ovidiu, Constanța County, Romania, 905900
        • Ovidius Clinical Hospital OCH
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Centrul de Oncologie "Sfântul Nectarie"
  • South Korea
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3080
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 6351
        • Samsung Medical Center
      • Songpagu, Seoul-teukbyeolsi [Seoul], South Korea, 5505
        • Asan Medical Center
  • Spain
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañon
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 8035
        • Hospital Universitari Vall d'Hebron
      • Hospitalet, Barcelona [Barcelona], Spain, 8907
        • Instituto Catalán de Oncología - Hospital Duran i Reynals
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 8036
        • Hospital Clínic de Barcelona
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Hospital Universitario 12 de octubre
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • St. Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona - Phoenix
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center - North Campus
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernards Medical Center
    • California
      • Bakersfield, California, United States, 93309
        • CBCC Global Research, Inc.
      • Fullerton, California, United States, 92835
        • Providence St. Jude Medical Center
      • La Jolla, California, United States, 92093
        • Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 100)
      • Los Angeles, California, United States, 90024
        • TRIO-US (Translational Research in Oncology-US)
      • Monterey, California, United States, 93940
        • Pacific Cancer Care
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic_Kendle
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Center
    • Florida
      • Hollywood, Florida, United States, 33024
        • Millennium Oncology - Hollywood
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • M Health Fairview University of Minnesota Medical Center - East Bank
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals - Urology
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Medical Center
    • Texas
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Medical Center - Temple
      • The Woodlands, Texas, United States, 77380
        • US Oncology
      • The Woodlands, Texas, United States, 77380
        • Northwest Cancer Specialists PC
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - Longview Cancer Center
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology Cancer Care and Research Center
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology Fort Worth
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology-Memorial City
      • The Woodlands, Texas, United States, 77380
        • USO-Cancer Care Center of Brevard, Inc.
      • The Woodlands, Texas, United States, 77380
        • New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
      • The Woodlands, Texas, United States, 77380
        • Sansum Clinic_Kendle
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Vermont
      • Burlington, Vermont, United States, 05405
        • The University of Vermont Medical Center Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Abemaciclib
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: Abemaciclib
Administered orally.
Other Names:
  • LY2835219
Drug: Prednisone
Administered orally.
Drug: Abiraterone acetate
Administered orally.
Placebo Comparator: Placebo
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: Placebo
Administered orally.
Drug: Prednisone
Administered orally.
Drug: Abiraterone acetate
Administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic Progression Free Survival (rPFS)
Time Frame: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Prostate-Specific Antigen (PSA) Progression
Time Frame: From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)
The PSA progression is defined as a greater than or equal to (>=) 25 percentage (%) increase and an absolute increase of >=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later.
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
Time Frame: From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
rPFS is defined as the time from the date of randomization to the earliest date of radiographic disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
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)
Time Frame: Baseline to Radiographic Disease Progression (Up to 60 Months)

ORR is a summary measure of best overall response (BOR) as defined by RECIST 1.1 for soft tissue per investigator assessment. BOR is derived from time point responses. All time point responses observed while on study treatment and during the short-term follow-up period (but before the initiation of post-discontinuation systemic anticancer therapy) will be included in the derivation.

Each patient's BOR will be categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). A BOR of CR or PR will require confirmation, but sensitivity analyses of response-based endpoints may be performed where confirmation of a BOR of CR or PR is not required.
Baseline to Radiographic Disease Progression (Up to 60 Months)
Duration of Response (DOR)
Time Frame: Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
The DoR time is defined only for responders (participants with a soft tissue BOR of CR or PR) in the measurable disease population. It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator determined radiographic disease progression or death from any cause, whichever is earlier.
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)
Time Frame: From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)
The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive.
From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)
Time to Symptomatic Progression
Time Frame: From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months)

Time to symptomatic progression is defined as the time from randomization to any of the following (whichever occurs earlier):

  1. Symptomatic Skeletal Event (SSE), defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression.
  2. Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy.
  3. Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months)
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Time Frame: Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean steady state exposure of abemaciclib.
Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Time Frame: C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean steady state exposure of abemaciclib metabolite LSN2839567.
C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Time Frame: C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean steady state exposure of abemaciclib metabolite LSN3106726.
C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean Steady State Exposure of Abiraterone Acetate
Time Frame: C1 D15, Post dose
PK: Mean Steady State Exposure of Abiraterone Acetate.
C1 D15, Post dose
Time to Worst Pain Progression
Time Frame: From Randomization Through Follow-up (Up to 60 months)
Time to Worst Pain Progression defined as the time from randomization to any of the following (whichever occurs earlier): For participants without opioid use at baseline (World Health Organization-Analgesic Ladder-WHO-AL ≤ 2):- Worst pain progression (an increase of 2 points from baseline on the Worst Pain Numeric Rating Scale (NRS) item on 2 consecutive evaluations), Initiation of weak or strong opioids (WHO-AL ≥ 3); For participants with weak or strong opioid use at baseline (WHO-AL ≥ 3): Worst pain progression (an increase of 2 points from baseline on the Worst Pain NRS item on 2 consecutive evaluations) without concurrent decreased opioid use (a decrease in WHO-AL of 1 or more) -Increased opioid use (an increase in WHO-AL of 1 or more).
From Randomization Through Follow-up (Up to 60 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16598
  • I3Y-MC-JPCM (Other Identifier: Eli Lilly and Company)
  • 2016-004276-21 (EudraCT Number)
  • 2023-506777-36-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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