A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

Condition: Prostate Cancer

Intervention:

  • Drug: Abemaciclib
  • Drug: Abiraterone Acetate
  • Drug: Prednisone
  • Drug: Placebo

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03706365

Sponsor: Eli Lilly and Company

Primary Outcome Measures:

  • Measure: Radiographic Progression Free Survival (rPFS)
  • Time Frame: Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
  • Safety Issue:
  • Measure: Time to Prostate-Specific Antigen (PSA) Progression
  • Time Frame: Baseline to the Date of the First Observation of PSA Progression (Estimated up to 21 Months)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
  • Time Frame: Baseline to Radiographic Disease Progression (Estimated up to 21 Months)
  • Safety Issue:
  • Measure: 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 21 Months)
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months)
  • Safety Issue:
  • Measure: Time to Symptomatic Progression
  • Time Frame: Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months)
  • Safety Issue:
  • Measure: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
  • Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
  • Safety Issue:
  • Measure: PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
  • Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
  • Safety Issue:
  • Measure: PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
  • Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
  • Safety Issue:
  • Measure: PK: Mean Steady State Exposure of Abiraterone Acetate
  • Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
  • Safety Issue:

Estimated Enrollment: 180

Study Start Date: November 27, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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
  • Be able and willing to undergo mandatory tumor biopsy of at least one metastatic site.
  • 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, 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).

Contact:

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 1-317-615-4559

Locations:

  • University of Arizona Cancer Center
  • Phoenix Arizona 85004 United States
  • Mayo Clinic Hospital
  • Phoenix Arizona 85054 United States
  • The University of Arizona Cancer Center
  • Tucson Arizona 85724 United States
  • St. Bernards Medical Center
  • Jonesboro Arkansas 72401 United States
  • Comprehensive Blood and Cancer Center
  • Bakersfield California 93309 United States
  • St. Joseph Heritage Healthcare
  • Fullerton California 92935 United States
  • University of California – San Diego
  • La Jolla California 92093 United States
  • UCLA Medical Center
  • Los Angeles California 90024 United States
  • TRIO – Translational Research in Oncology-US, Inc.
  • Los Angeles California 90095 United States
  • Pacific Cancer Care
  • Monterey California 93940 United States
  • Rocky Mountain Cancer Center
  • Lone Tree Colorado 80124 United States
  • Yale University School of Medicine
  • New Haven Connecticut 06510 United States
  • Millennium Oncology
  • Hollywood Florida 33024 United States
  • Hematology Oncology Associates of Treasure Coast
  • Port Saint Lucie Florida 34952 United States
  • Northside Hospital Cancer Institute
  • Marietta Georgia 30060 United States
  • Fort Wayne Oncology & Hematology
  • Fort Wayne Indiana 46845 United States
  • Norton Cancer Institute
  • Louisville Kentucky 40202 United States
  • Maryland Oncology Hematology, P.A.
  • Rockville Maryland 20850 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02115 United States
  • Southcoast Centers for Cancer Care
  • Fairhaven Massachusetts 02179 United States
  • University of Minnesota Hospital
  • Minneapolis Minnesota 55455 United States
  • Research Medical Center
  • Kansas City Missouri 63142 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89169 United States
  • New York Oncology Hematology, P.C
  • Albany New York 12208 United States
  • Associated Medical Professionals of NY
  • Syracuse New York 13210 United States
  • Mission SECU Cancer Center
  • Asheville North Carolina 28801 United States
  • Oklahoma Cancer Specialists & Research Institute, LLC
  • Tulsa Oklahoma 74146 United States
  • Northwest Cancer Specialists PC
  • Tigard Oregon 97223 United States
  • University of Tennessee Medical Center
  • Knoxville Tennessee 37920 United States
  • Sarah Cannon Research Institute SCRI
  • Nashville Tennessee 37203 United States
  • Southwestern Medical Center – Dallas
  • Dallas Texas 75390 United States
  • Texas Oncology Fort Worth
  • Fort Worth Texas 76104 United States
  • Texas Oncology-Memorial City
  • Houston Texas 77024 United States
  • Scott & White Memorial Hospital & Clinic
  • Temple Texas 76508 United States
  • US Oncology
  • The Woodlands Texas 77380 United States
  • Texas Oncology Cancer Care and Research Center
  • Waco Texas 76712 United States
  • University of Utah School of Medicine
  • Salt Lake City Utah 84132 United States
  • University of Vermont Medical Center
  • Burlington Vermont 05401 United States
  • Chris O’Brien Lifehouse
  • Camperdown New South Wales 2050 Australia
  • Southside Cancer Care Centre
  • Kogarah New South Wales 2228 Australia
  • Macquarie University Hospital
  • Macquarie Park New South Wales 2109 Australia
  • Prince of Wales Hospital
  • Randwick New South Wales 2031 Australia
  • St Vincents Hospital Melbourne
  • Fitzroy Victoria 3065 Australia
  • Finsen Institute
  • Copenhagen 2100 Denmark
  • Næstved Sygehus
  • Næstved 4700 Denmark
  • Studienpraxis Urologie
  • Nürtingen Baden-Württemberg 72622 Germany
  • Universitätsklinikum Münster
  • Münster Nordrhein-Westfalen 48149 Germany
  • Universitätsklinikum Tübingen
  • Tübingen 72076 Germany
  • Samsung Medical Center
  • Seoul Korea 06351 Korea, Republic of
  • Seoul National University Hospital
  • Seoul 03080 Korea, Republic of
  • Severance Hospital Yonsei University Health System
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Canisius-Wilhelmina Ziekenhuis
  • Nijmegen Gelderland 6532 SZ Netherlands
  • Erasmus Medisch Centrum
  • Rotterdam South Holland 3015 GD Netherlands
  • St. Antonius Ziekenhuis, locatie Nieuwegein
  • Utrecht 3543 AZ Netherlands
  • Puerto Rico Hematology/Oncology Group
  • Bayamon 00961 Puerto Rico
  • Centrul de Oncologie Sf. Nectarie SRL
  • Craiova Dolj 200347 Romania
  • S.C. R.T.C. Radiology Therapeutic Center S.R.L.
  • Otopeni Ilfov 075100 Romania
  • SC Gral Medical SRL
  • Bucuresti 031422 Romania
  • Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
  • Constanta 900591 Romania
  • Hospital Clinico Universitario Virgen de la Victoria
  • Malaga Andalucia 29010 Spain
  • Institut Catala d’Oncologia
  • L’Hospitalet de Llobregat Barcelona 08907 Spain
  • Hospital Universitari Vall d’Hebron
  • Barcelona 08035 Spain
  • Hospital Clinic I Provincial
  • Barcelona 08036 Spain
  • Hospital General Universitario Gregorio Marañon
  • Madrid 28007 Spain
  • Hospital Universitario Ramon y Cajal
  • Madrid 28034 Spain
  • Hospital Universitario 12 de Octubre
  • Madrid 28041 Spain
  • Derriford Hospital
  • Plymouth Devon PL6 8DH United Kingdom
  • University College Hospital – London
  • London Greater London NW1 2BU United Kingdom
  • Charing Cross Hospital
  • Chelsea London W6 8RF United Kingdom
  • Northampton General Hospital
  • Northampton NN1 5BD United Kingdom

View trial on ClinicalTrials.gov

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