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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03706365
Collaborator
(none)
350
Enrollment
118
Locations
6
Arms
90.6
Anticipated Duration (Months)
3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 26, 2018
Anticipated Primary Completion Date :
Dec 13, 2023
Anticipated Study Completion Date :
Jun 15, 2026

Arms and Interventions

ArmIntervention/Treatment
Experimental: A1. Abiraterone plus Prednisone and Abemaciclib

Abiraterone plus prednisone administered orally and abemaciclib administered orally.

Drug: Abemaciclib
Administered orally.
Other Names:
  • LY2835219
  • Drug: Abiraterone Acetate
    Administered orally.

    Drug: Prednisone
    Administered orally.

    Experimental: A2. Abiraterone plus Prednisone and Abemaciclib

    Abiraterone plus prednisone administered orally and abemaciclib administered orally.

    Drug: Abemaciclib
    Administered orally.
    Other Names:
  • LY2835219
  • Drug: Abiraterone Acetate
    Administered orally.

    Drug: Prednisone
    Administered orally.

    Active Comparator: B1. Abiraterone plus Prednisone and Placebo

    Abiraterone plus prednisone administered orally and placebo administered orally.

    Drug: Abiraterone Acetate
    Administered orally.

    Drug: Prednisone
    Administered orally.

    Drug: Placebo
    Administered orally.

    Active Comparator: B2. Abiraterone plus Prednisone and Placebo

    Abiraterone plus prednisone administered orally and placebo administered orally.

    Drug: Abiraterone Acetate
    Administered orally.

    Drug: Prednisone
    Administered orally.

    Drug: Placebo
    Administered orally.

    Experimental: A. Abiraterone plus Prednisone and Abemaciclib

    Abiraterone plus prednisone administered orally and abemaciclib administered orally.

    Drug: Abemaciclib
    Administered orally.
    Other Names:
  • LY2835219
  • Drug: Abiraterone Acetate
    Administered orally.

    Drug: Prednisone
    Administered orally.

    Active Comparator: B. Abiraterone plus Prednisone and Placebo

    Abiraterone plus prednisone administered orally and placebo administered orally.

    Drug: Abiraterone Acetate
    Administered orally.

    Drug: Prednisone
    Administered orally.

    Drug: Placebo
    Administered orally.

    Outcome Measures

    Primary Outcome Measures

    1. Radiographic Progression Free Survival (rPFS) [Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)]

      rPFS by investigator assessment

    Secondary Outcome Measures

    1. Time to Prostate-Specific Antigen (PSA) Progression [Baseline to the Date of the First Observation of PSA Progression (Estimated up to 21 Months)]

      Time to PSA progression

    2. Radiographic Progression Free Survival (rPFS) [Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)]

      rPFS by blinded, independent, central review

    3. Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) [Baseline to Radiographic Disease Progression (Estimated up to 21 Months)]

      ORR: Percentage of participants with a CR or PR

    4. Duration of Response (DOR) [Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)]

      DOR

    5. Overall Survival (OS) [Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months)]

      OS

    6. Time to Symptomatic Progression [Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months)]

      Time to symptomatic progression

    7. Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib [Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)]

      PK: Mean steady state exposure of abemaciclib

    8. PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 [Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)]

      PK: Mean steady state exposure of abemaciclib metabolite LSN2839567

    9. PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 [Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)]

      PK: Mean steady state exposure of abemaciclib metabolite LSN3106726

    10. PK: Mean Steady State Exposure of Abiraterone Acetate [Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)]

      PK: Mean Steady State Exposure of Abiraterone Acetate

    11. Time to Worst Pain Progression [Baseline through follow-up (Estimated up to 21 months)]

      Measured by the Worst Pain Numeric Rating Scale (NRS) and World Health Organization-Analgesic Ladder (WHO-AL). NRS score measures worst pain over the last 24 hours on a 0 to 10-point NRS, where 0 -s "no pain" and 10 is "pain as bad as you can imagine. The WHO-AL classifies analgesic use into four categories, where 1 = no analgesic and 4 = strong opioids.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Arizona Cancer CenterPhoenixArizonaUnited States85004
    2Mayo Clinic HospitalPhoenixArizonaUnited States85054
    3The University of Arizona Cancer CenterTucsonArizonaUnited States85719
    4St. Bernards Medical CenterJonesboroArkansasUnited States72401
    5Comprehensive Blood and Cancer CenterBakersfieldCaliforniaUnited States93309
    6St. Joseph Heritage HealthcareFullertonCaliforniaUnited States92935
    7University of California - San DiegoLa JollaCaliforniaUnited States92037
    8UCLA Medical CenterLos AngelesCaliforniaUnited States90024
    9TRIO - Translational Research in Oncology-US, Inc.Los AngelesCaliforniaUnited States90095
    10Pacific Cancer CareMontereyCaliforniaUnited States93940
    11Sansum ClinicSanta BarbaraCaliforniaUnited States93105
    12Rocky Mountain Cancer CenterLone TreeColoradoUnited States80124
    13Millennium OncologyHollywoodFloridaUnited States33024
    14Cancer Care Center of BrevardPalm BayFloridaUnited States32909
    15Northside Hospital Cancer InstituteMariettaGeorgiaUnited States30060
    16Fort Wayne Medical Oncology & Hematology, Inc.Fort WayneIndianaUnited States46804
    17Maryland Oncology Hematology, P.A.RockvilleMarylandUnited States20850
    18Massachusetts General HospitalBostonMassachusettsUnited States02115
    19University of Minnesota HospitalMinneapolisMinnesotaUnited States55455
    20Research Medical CenterKansas CityMissouriUnited States63142
    21Comprehensive Cancer Centers of NevadaLas VegasNevadaUnited States89169
    22New York Oncology Hematology, P.CAlbanyNew YorkUnited States12208
    23Associated Medical Professionals of NYSyracuseNew YorkUnited States13210
    24Northwest Cancer Specialists PCTigardOregonUnited States97223
    25Texas Oncology Fort WorthFort WorthTexasUnited States76104
    26Texas Oncology-Memorial CityHoustonTexasUnited States77024
    27Texas Oncology - Longview Cancer CenterLongviewTexasUnited States75601
    28Scott & White Memorial Hospital & ClinicTempleTexasUnited States76508
    29US OncologyThe WoodlandsTexasUnited States77380
    30Texas Oncology Cancer Care and Research CenterWacoTexasUnited States76712
    31University of Utah School of MedicineSalt Lake CityUtahUnited States84132
    32University of Vermont Medical CenterBurlingtonVermontUnited States05401
    33Chris O'Brien LifehouseCamperdownNew South WalesAustralia2050
    34Southside Cancer Care CentreKogarahNew South WalesAustralia2228
    35Macquarie University HospitalMacquarie ParkNew South WalesAustralia2109
    36Prince of Wales HospitalRandwickNew South WalesAustralia2031
    37St Vincents Hospital MelbourneFitzroyVictoriaAustralia3065
    38Peter MacCallum Cancer CentreMelbourneVictoriaAustralia3000
    39Lanzhou university second hospitalLanzhouGansuChina730030
    40Sun Yat-sen University Cancer CenterGuangzhouGuangdongChina510060
    41Haikou people's hospitalHaikouHainanChina570206
    42Yijishan Hospital of Wannan Medical CollegeWuhuHefeiChina2410000
    43Harbin Medical University Cancer HospitalHarbinHeilongjiangChina150081
    44The First Affiliated Hospital of Henan University of Science &TechnologyLuoyangHenanChina471003
    45Wu Han Tongji HospitalWuhan CityHubeiChina430030
    46Union Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhanHubeiChina430022
    47Hunan Cancer HospitalChangshaHunanChina410013
    48Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjingJiangsuChina210000
    49Nantong Tumor HospitalNantongJiangsuChina226000
    50Wuxi People's HospitalWuxiJiangsuChina214023
    51The First Affiliated Hospital of Nanchang UniversityNanchangJiangxiChina
    52Jilin Province People's HospitalChangchunJilinChina130021
    53Yantai Yuhuangding hospitalYantaiShandongChina264000
    54HuaShan Hospital Affiliated To Fudan UniversityShanghaiShanghaiChina20040
    55Nanchong Central HospitalNanchongSichuanChina637000
    56The Second Hospital of Tianjin Medical UniversityTianjinTianjinChina300211
    57Tianjin Medical University Cancer Institute & HospitalTianjinTianjinChina
    58Xinjiang Medical University Cancer HospitalUrumqiXinjiangChina830000
    59First Affiliated Hosp of College of Med, Zhejiang UniversityHangzhouZhejiangChina310003
    60Zhejiang Provincial People's HospitalHangzhouZhejiangChina310014
    61People's Hospital of Hunan ProvinceChangshaChina410002
    62Second affiliated hospital of anhui medical universityHe FeiChina230000
    63Fudan University Shanghai Cancer CenterShanghaiChina200032
    64Xinhua Hopstial Aff. to Shanghai Jiaotong Univ Sch of MedShanghaiChina200092
    65The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'AnChina710061
    66Finsen InstituteCopenhagenDenmark2100
    67Næstved SygehusNæstvedDenmark4700
    68Centre Hospitalier de la Côte BasqueBayonneFrance64109
    69CHU de Bordeaux Hopital Saint AndreBordeauxFrance33075
    70CHU Henri MondorCreteil CedexFrance94010
    71CHD VendeeLa Roche Sur YonFrance85025
    72Clinique Victor Hugo - Centre Jean BernardLe MansFrance72000
    73Centre Leon BerardLyon Cedex 08France69373
    74Centre de Cancérologie du Grand MontpellierMontpellierFrance34070
    75Studienpraxis UrologieNürtingenBaden-WürttembergGermany72622
    76Gesundheitszentrum HolzmindenHolzmindenNiedersachsenGermany37603
    77Universitätsklinikum MünsterMünsterNordrhein-WestfalenGermany48149
    78Urologie Neandertal - Praxis MettmannMettmannNorth Rhine-WestphaliaGermany40822
    79Urologische Gemeinschaftspraxis WeselWeselNorth Rhine-WestphaliaGermany46483
    80Urologische Arztpraxis in Eisleben - Dr. med. Ralf EckertLutherstadt EislebenSaxony-AnhaltGermany06295
    81Urologie am Nordplatz - Urologische Facharztpraxis Dr. med. Silvio SzymulaLeipzigSaxonyGermany04105
    82Urologie Bayenthal in KölnKölnGermany50968
    83Universitätsklinikum TübingenTübingenGermany72076
    84Red Cross Aichi HospitalNagoyaAichiJapan466-0814
    85Hirosaki University HospitalHirosakiAomoriJapan036-8563
    86Toho University School of Medicine, Sakura HospitalSakuraChibaJapan285-8741
    87Hokkaido University HospitalSapporoHokkaidoJapan060-8648
    88Kobe City Medical Center General HospitalKobeHyogoJapan650-0047
    89Kanazawa University HospitalKanazawaIshikawaJapan920 8641
    90Yokohama City University Medical CenterYokohamaKanagawaJapan232-0024
    91Saitama Cancer CenterKita-AdachiSaitamaJapan362-0806
    92Hamamatsu University School of Medicine, University HospitalHamamatsuShizuokaJapan431-3192
    93Showa University HospitalShinagawa-kuTokyoJapan142-8666
    94Gifu University HospitalGifuJapan501-1194
    95National Kumamoto HospitalKumamotoJapan860-0008
    96Osaka International Cancer InstituteOsakaJapan541-8567
    97Seoul National University HospitalSeoulSeoul, KoreaKorea, Republic of03080
    98Asan Medical CenterSeoulSeoul-teukbyeolsi [Seoul]Korea, Republic of05505
    99Samsung Medical CenterSeoulSeoul-teukbyeolsi [Seoul]Korea, Republic of06351
    100Severance HospitalSeoulKorea, Republic of03722
    101Canisius-Wilhelmina ZiekenhuisNijmegenGelderlandNetherlands6532 SZ
    102Erasmus Medisch CentrumRotterdamSouth HollandNetherlands3015 GD
    103St. Antonius Ziekenhuis, locatie NieuwegeinUtrechtNetherlands3543 AZ
    104Centrul de Oncologie "Sfântul Nectarie"CraiovaDoljRomania200347
    105S.C. R.T.C. Radiology Therapeutic Center S.R.L.OtopeniIlfovRomania075100
    106SC Gral Medical SRLBucurestiRomania031422
    107Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei ConstantaConstantaRomania900591
    108Hospital Universitario Virgen de la VictoriaMalagaAndaluciaSpain29010
    109Institut Catala d'OncologiaL'Hospitalet de LlobregatBarcelonaSpain08907
    110Hospital Universitari Vall d'HebronBarcelonaSpain08035
    111Hospital Clinic I ProvincialBarcelonaSpain08036
    112Hospital General Universitario Gregorio MaranonMadridSpain28007
    113Hospital Universitario Ramon y CajalMadridSpain28034
    114Hospital Universitario 12 de OctubreMadridSpain28041
    115Derriford HospitalPlymouthDevonUnited KingdomPL6 8DH
    116University College Hospital - LondonLondonGreater LondonUnited KingdomNW1 2BU
    117Charing Cross HospitalChelseaLondonUnited KingdomW6 8RF
    118Northampton General HospitalNorthamptonUnited KingdomNN1 5BD

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03706365
    Other Study ID Numbers:
    • 16598
    • I3Y-MC-JPCM
    • 2016-004276-21
    First Posted:
    Oct 16, 2018
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021