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Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1)

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ClinicalTrials.gov Identifier: NCT04408924
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.

Condition or disease Intervention/treatment Phase
Metastatic Castration-Resistant Prostate Cancer Drug: Abemaciclib Phase 2

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 : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : March 23, 2022
Estimated Study Completion Date : March 13, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Abemaciclib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Abemaciclib
Abemaciclib given orally.
 Drug: Abemaciclib
Administered orally
Other Name: LY2835219


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Objective Radiographic Soft Tissue Disease Progression (Estimated up to 12 Months) ]
    ORR: Percentage of Participants with Best Response of CR or PR


Secondary Outcome Measures :
  1. Radiographic Progression-Free Survival (rPFS) [ Time Frame: Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 12 Months) ]
    rPFS

  2. Overall Survival (OS) [ Time Frame: Baseline to Date of Death Due to Any Cause (Estimated up to 24 Months) ]
    OS

  3. Duration of Response (DOR) [ Time Frame: Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Estimated up to 12 Months) ]
    DoR

  4. Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline to Radiographic Soft Tissue Disease Progression (Estimated up to 12 Months) ]
    DCR: Percentage of participants who exhibit SD, CR or PR

  5. Prostate Specific Antigen (PSA) Response Rate [ Time Frame: Baseline to Date of Treatment Discontinuation (Estimated up to 12 Months) ]
    PSA Response Rate: Percentage of Participants with a PSA Decrease of at Least 50% from Baseline

  6. Time to PSA Progression [ Time Frame: Baseline to the Date of First Observation of PSA Progression (Estimated up to 12 Months) ]
    Time to PSA Progression

  7. Time to Symptomatic Progression [ Time Frame: Baseline to the Date of First Documented Symptomatic Progression (Estimated up to 12 Months) ]
    Time to Symptomatic Progression

  8. Patient-Reported Outcomes (PRO) [ Time Frame: Baseline to End of Study (Estimated up to 12 Months) ]
    Patient-reported tolerability, including select symptomatic adverse events (from the PRO-Common Terminology Criteria for Adverse Events item library) and overall side-effect burden (item GP5 of the Functional Assessment of Cancer Therapy Tool General form (FACT-G))

  9. Pharmacokinetics (PK): Mean Steady State Concentration of Abemaciclib and its Metabolites [ Time Frame: Predose Cycle 1 Day 15 through Predose Cycle 3 Day 1 (28 Day Cycles) ]
    PK: Mean Steady State Concentration of Abemaciclib and its Metabolites

  10. Percentage of Ki-67 Positive Cells by Immunohistochemistry (IHC) [ Time Frame: Baseline ]
    Percentage of Ki-67 positive cells by IHC


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:

  • Participant must have metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant).
  • Participant must have disease spread to soft tissue that is measurable.
  • Participant must have documented evidence of progressive disease by PSA test or imaging.
  • Participant must have previously received at least one of the following treatment: abiraterone acetate, apalutamide, darolutamide or enzalutamide.
  • Participant must have previously received chemotherapy with docetaxel and cabazitaxel.
  • Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research.
  • Participant must have good physical functioning ability and adequate organ function.

Exclusion Criteria:

  • Participant must not have received more than 3 therapy regimens for metastatic castration-resistant prostate cancer (NOTE: GnRHa, first-generation antiandrogens (flutamide, nilutamide, or bicalutamide), diethylstilbestrol (DES) (or other estrogens), corticosteroids, ketoconazole, and bone loss-prevention will not count as systemic therapy regimens.
  • Participants must not have previously received abemaciclib or any cyclin-dependent kinase (CDK)4 and/or CDK6 inhibitors.
  • Participants must not have serious and/or uncontrolled preexisting medical condition(s) including but not limited to severe renal impairment, severe hepatic impairment, interstitial lung disease (ILD)/pneumonitis, severe dyspnea at rest or requiring oxygen therapy or other serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
  • Participants must not have, or suspected to have, brain metastasis.
  • Participants must not have untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression or structurally unstable bone lesions suggesting impending fracture.
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): NCT04408924


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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United States, Florida
Moffitt Cancer Center & Research Inst Not yet recruiting
Tampa, Florida, United States, 33612
Contact    813-745-4673      
Principal Investigator: Jad Chahoud         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact    617-726-2943      
Principal Investigator: Matthew Smith         
United States, Utah
University of Utah - Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact    801-213-5658      
Principal Investigator: Neeraj Agarwal         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98109
Contact    206-606-6252      
Principal Investigator: Michael Schweizer         
France
Centre Leon Berard Recruiting
Lyon Cedex 08, France, 69373
Contact    0033478782643      
Principal Investigator: Aude Flechon         
Institut Paoli-Calmettes Recruiting
Marseille, France, 13273
Contact    0033491223760      
Principal Investigator: Gwenaelle Gravis         
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact    0033156093447      
Principal Investigator: Stephane Oudard         
Institut Claudius Regaud - IUCT Oncopole Recruiting
Toulouse cedex 9, France, 31059
Contact    0033531155151      
Principal Investigator: Loic Mourey         
Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Contact    0033142114571      
Principal Investigator: Emeline Colomba-Blameble         
Spain
Institut Catala d'Oncologia Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact    0034932607744      
Principal Investigator: José María Piulats Rodríguez         
Corporacion Sanitaria Parc Tauli Recruiting
Sabadell, Barcelona, Spain, 08208
Contact    0034937458272      
Principal Investigator: Enrique Gallardo Díaz         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact    0034935537116      
Principal Investigator: Pablo Maroto Rey         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact    0034932746000      
Principal Investigator: Joaquin Mateo         
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact    0034914269070      
Principal Investigator: Jose Ángel Arranz Arija         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact    0034913368263      
Principal Investigator: Teresa Alonso Gordoa         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact    0034913908626      
Principal Investigator: Daniel Castellano Gauna         
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: NCT04408924    
Other Study ID Numbers: 17583
I3Y-MC-JPCY ( Other Identifier: Eli Lilly and Company )
2020-000290-24 ( EudraCT Number )
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 1, 2021
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 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:
mCRPC
CDK4
CDK6
CDK4/6
CDK4&6 inhibitor
 CDK4/6 inhibitor
LY2835219
CYCLONE 1
CYCLONE1
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases