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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) (CYCLONE 3)

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ClinicalTrials.gov Identifier: NCT05288166
Recruitment Status : Recruiting
First Posted : March 21, 2022
Last Update Posted : May 24, 2023
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 10, 2022
First Posted Date  ICMJE March 21, 2022
Last Update Posted Date May 24, 2023
Actual Study Start Date  ICMJE April 14, 2022
Estimated Primary Completion Date October 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2022)
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator [ Time Frame: Randomization to radiographic progression or death from any cause (approximately 48 months) ]
rPFS Assessed by Investigator
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2022)
  • rPFS Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Randomization to radiographic progression or death from any cause (approximately 48 months) ]
    rPFS Assessed by BICR
  • Castration-resistant Prostate Cancer (CRPC)-free Survival [ Time Frame: Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 nanogram/deciliter (ng/dL); or death from any cause (approximately 48 months) ]
    CRPC-free Survival
  • Overall Survival (OS) [ Time Frame: Baseline to date of death due to any cause (approximately 60 months) ]
  • Time to Pain Progression [ Time Frame: Randomization to pain progression (approximately 48 months) ]
    Measured by a combination of 2 scales, the Brief Pain Inventory Short Form (BPI-SF) Worst Pain Numeric Rating Scale (NRS) and the Analgesic Quantification Algorithm (AQA) scale. The BPI-SF Worst Pain NRS is a self-reported 11-item questionnaire on worst pain intensity on the past 24 hours. Score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). The AQA scores analgesic use from 0 (minimum) to 7 (maximum).
  • Time to Deterioration in Health-Related Quality of Life (HRQoL) [ Time Frame: Randomization to the date of HRQoL deterioration (approximately 48 Months) ]
    Measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P; Physical well-being and Prostate Cancer Subscale). The FACT-P is a 39-item self-reported questionnaire that assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life.
  • Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib [ Time Frame: Postdose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles) ]
    PK: Mean steady state exposure of abemaciclib
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostatic Neoplasms
  • Neoplasm Metastasis
  • Urogenital Neoplasms
  • Physiological Effects of Drugs
  • Antineoplastic Agents
  • Antineoplastic Agents, Hormonal
  • Androgens
  • Hormones
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Abiraterone Acetate
  • Steroid Synthesis Inhibitors
  • Cytochrome P-450
  • Enzyme Inhibitors
  • Prednisone
  • Prednisolone
  • Cyclin-Dependent Kinase 4
  • Cyclin-Dependent Kinase 6
Intervention  ICMJE
  • Drug: Abemaciclib
    Administered orally.
    Other Name: LY2835219
  • Drug: Abiraterone
    Administered orally.
  • Drug: Prednisone or Prednisolone
    Administered orally.
  • Drug: Placebo for Abemaciclib
    Administered orally.
Study Arms  ICMJE
  • Experimental: Abemaciclib + Abiraterone + Prednisone/Prednisolone
    Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.
    • Drug: Abemaciclib
    • Drug: Abiraterone
    • Drug: Prednisone or Prednisolone
  • Active Comparator: Placebo + Abiraterone + Prednisone/Prednisolone
    Placebo + abiraterone + prednisone/prednisolone administered orally.
    • Drug: Abiraterone
    • Drug: Prednisone or Prednisolone
    • Drug: Placebo for Abemaciclib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2022)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2027
Estimated Primary Completion Date October 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Romania,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Russian Federation
Administrative Information
NCT Number  ICMJE NCT05288166
Other Study ID Numbers  ICMJE 18448
I3Y-MC-JPEG ( Other Identifier: Eli Lilly and Company )
2022-500461-28-06 ( Other Identifier: EU Trial Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 7, 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP