A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

Phase
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Eli Lilly and Company
Start date
Number of sites

Summary
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
Acronym
Short title
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
Official title
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer

Control arm
Active comparator
Registry reports results
Listing at source
Recruitment status
Active, not recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Eli Lilly and Company
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

  1. Radiographic Progression-Free Survival (rPFS) Assessed by Investigator

    Timeframe: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 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.

  1. Radiographic Progression-Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR)

    Timeframe: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 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.

  2. Castration-resistant Prostate Cancer (CRPC)-Free Survival

    Timeframe: Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 ng/dL; or death from any cause (up to 22 months)

    CRPC-free survival is defined as the time from the date of randomization to the earliest date of castration resistance, as demonstrated by any of the following (whichever occurs earliest): Confirmed prostate-specific antigen (PSA) progression with serum testosterone ≤50 nanogram/deciliter (ng/dL) (≤1.73 nanomoles per liter(nmol/L)). Investigator-assessed radiographic progression with serum testosterone ≤50 ng/dL (≤1.73 nmol/L). Death from any cause.

  3. Overall Survival (OS)

    Timeframe: From Date of Randomization to Date of Death Due to Any Cause (Up to 22 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.

  4. Time to Pain Progression

    Timeframe: Randomization to pain progression (up to 22 months)

  5. Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Physical Well-Being Subscale

    Timeframe: Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)

    Time to deterioration in health-related quality of life (HRQoL) was defined as the time from randomization to the date of the first clinically meaningful HRQoL deterioration on 2 consecutive measurements. HRQoL evaluation was performed using the FACT-P questionnaire. Physical Well-Being subscale is a subsection of FACT-P questionnaire. FACT-P consists of 39 core items to assess health related quality of life in participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate cancer subscale (12 items). Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores. FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to 156 with higher score indicating better quality of life. Physical well-being subscale score ranges from 0 to 28 with high score indicating better quality of life.

  6. Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Prostate Cancer Subscale

    Timeframe: Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)

    Time to deterioration in health-related quality of life (HRQoL) was defined as the time from randomization to the date of the first clinically meaningful HRQoL deterioration on 2 consecutive measurements. HRQoL evaluation was performed using the FACT-P questionnaire. Prostate Cancer Subscale is a subsection of FACT-P questionnaire. FACT-P consists of 39 core items to assess health related quality of life in participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate cancer subscale (12 items). Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores. FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to 156 with higher score indicating better quality of life. Prostate cancer subscale score ranges from 0 to 48 with high score indicating better quality of life.

  7. Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib

    Timeframe: Predose on Cycle 1 Day 1, Predose and Predose on Cycle 2 Day 1 and Predose on Cycle 3 Day 1 (28 Day Cycles)

    Maximum plasma concentration at steady state (Cmax,ss) of abemaciclib was evaluated.

Sources for outcomes

Sex
Male
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Adenocarcinoma of the prostate (as the predominant histology)

  • High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:

    • Greater than or equal to (≥)4 bone metastases by bone scan and/or
    • ≥1 visceral metastases by computed tomography or magnetic resonance imaging
  • Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.

  • Adequate organ function

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 & 6) inhibitor
  • Development of metastatic prostate cancer in the context of castrate levels of testosterone
  • Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
  • Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
  • History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
  • Uncontrolled hypertension
  • Clinically active or chronic liver disease, moderate/severe hepatic impairment
  • Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization
Sources for eligibility

  • Arizona Oncology Associates, P.C. - HOPEPrescott, United States
  • Arizona Oncology Associates, P.C. - HOPEPrescott Valley, United States
  • The University of Arizona Cancer Center - North CampusTucson, United States
  • Genesis Cancer and Blood InstituteHot Springs, United States
  • St. Bernards Medical CenterJonesboro, United States
  • Highlands Oncology GroupSpringdale, United States
  • Orange Coast Memorial Medical CenterFountain Valley, United States
  • Providence Medical FoundationFullerton, United States
  • Moores Cancer CenterLa Jolla, United States
  • MemorialCare Health System - Long Beach Medical CenterLong Beach, United States
  • Cancer and Blood Specialty ClinicLos Alamitos, United States
  • UCLA Hematology/Oncology - Santa MonicaLos Angeles, United States
  • Torrance Memorial Physician Network / Cancer CareTorrance, United States
  • PIH Health Hematology Medical OncologyWhittier, United States
  • University of Colorado Anschutz Medical CampusAurora, United States
  • UCHealth Memorial HospitalColorado Springs, United States
  • UCHealth HarmonyFort Collins, United States
  • Colorado West Healthcare System - Grand Valley OncologyGrand Junction, United States
  • USO-Rocky Mountain Cancer CenterLittleton, United States
  • Florida Cancer Specialists - SouthFort Myers, United States
  • Memorial Regional HospitalHollywood, United States
  • Millennium Oncology Research ClinicHollywood, United States
  • University of Miami Hospital and Clinics, Sylvester Cancer CenterMiami, United States
  • Florida Cancer Specialist- EastWest Palm Beach, United States
  • Dwight D Eisenhower Army Medical CenterFort Gordon, United States

And 241 more, listed on the interactive page.

Sources for sites

  • 2022-500461-28-06
  • I3Y-MC-JPEG
Sources for references

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (7)