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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 : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: Abemaciclib Drug: Abiraterone Drug: Prednisone or Prednisolone Drug: Placebo for Abemaciclib Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 14, 2022
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Abemaciclib + Abiraterone + Prednisone/Prednisolone
Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.
 Drug: Abemaciclib
Administered orally.
Other Name: LY2835219

Drug: Abiraterone
Administered orally.

Drug: Prednisone or Prednisolone
Administered orally.
Active Comparator: Placebo + Abiraterone + Prednisone/Prednisolone
Placebo + abiraterone + prednisone/prednisolone administered orally.
 Drug: Abiraterone
Administered orally.

Drug: Prednisone or Prednisolone
Administered orally.

Drug: Placebo for Abemaciclib
Administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Overall Survival (OS) [ Time Frame: Baseline to date of death due to any cause (approximately 60 months) ]
    OS

  4. 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).

  5. 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.

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05288166


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05288166    
Other Study ID Numbers: 18448
I3Y-MC-JPEG ( Other Identifier: Eli Lilly and Company )
2022-500461-28-06 ( Other Identifier: EU Trial Number )
First Posted: March 21, 2022    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 7, 2023
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Metastatic Hormone Sensitive Prostate Cancer
mHSPC
Stage IV Prostate Cancer
Recurrent Prostate Cancer
De Novo Metastatic Prostate Cancer
High-Risk
 Visceral metastasis
Cyclin-Dependent Kinase 4 (CDK4)
Cyclin-Dependent Kinase 6 (CDK6)
CDK4
CDK6
CDK4/6
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Neoplasm Metastasis
Urogenital Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
 Immune System Diseases
Prednisone
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents