Clinical Trial - NCT03706365

       

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

Recruiting

Sponsor: Eli Lilly and Company

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03706365

Protocol Info

Short Description: Abiraterone Acetate + Prednisone +/- Abemaciclib in Prostate
Long Description: 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
MGH Status: Closed
Sponsor: Eli Lilly
Disease Program: GU

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




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. Prednisolone may be used instead of prednisone per local regulation.
Condition Title Intervention Phase
Prostate Cancer Abemaciclib Abiraterone Acetate Prednisone Placebo Phase 2
Study Type Interventional
Official Title 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

Primary Outcome Measures

Radiographic Progression Free Survival (rPFS) [Time Frame: Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]


Secondary Outcome Measures

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)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months)] [Designated as safety issue: ]

Time to Symptomatic Progression [Time Frame: Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months)] [Designated as safety issue: ]

Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib [Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]

PK: Mean Steady State Exposure of Abiraterone Acetate [Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)] [Designated as safety issue: ]

Estimated Enrollment: 180
Study Start Date: November 2018
Estimated Study Completion Date: February 2024
Estimated Primary Completion Date: September 2021
Arms Assigned Interventions

Experimental:A1. Abiraterone plus Prednisone and Abemaciclib

Abiraterone plus prednisone administered orally and abemaciclib administered orally.

Experimental:A2. Abiraterone plus Prednisone and Abemaciclib

Abiraterone plus prednisone administered orally and abemaciclib administered orally.

Active Comparator:B1. Abiraterone plus Prednisone and Placebo

Abiraterone plus prednisone administered orally and placebo administered orally.

Active Comparator:B2. Abiraterone plus Prednisone and Placebo

Abiraterone plus prednisone administered orally and placebo administered orally.

Experimental:A. Abiraterone plus Prednisone and Abemaciclib

Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Drug:Prednisone
Administered orally.

Active Comparator:B. Abiraterone plus Prednisone and Placebo

Abiraterone plus prednisone administered orally and placebo administered orally.
Drug:Placebo
Administered orally.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Male

Accepts Healthly 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
  • • 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, 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT03706365

Locations

  • United States, Arizona
    • University of Arizona Cancer Center Phoenix, Arizona, United States, 85004
    • Mayo Clinic Hospital Phoenix, Arizona, United States, 85054
    • The University of Arizona Cancer Center Tucson, Arizona, United States, 85719
  • United States, Arkansas
    • St. Bernards Medical Center Jonesboro, Arkansas, United States, 72401
  • United States, California
    • Comprehensive Blood and Cancer Center Bakersfield, California, United States, 93309
    • St. Joseph Heritage Healthcare Fullerton, California, United States, 92935
    • University of California - San Diego La Jolla, California, United States, 92037
    • UCLA Medical Center Los Angeles, California, United States, 90024
    • TRIO - Translational Research in Oncology-US, Inc. Los Angeles, California, United States, 90095
    • Pacific Cancer Care Monterey, California, United States, 93940
    • Sansum Clinic Santa Barbara, California, United States, 93105
  • United States, Colorado
    • Rocky Mountain Cancer Center Lone Tree, Colorado, United States, 80124
  • United States, Connecticut
    • Yale University School of Medicine New Haven, Connecticut, United States, 06510
  • United States, Florida
    • Millennium Oncology Hollywood, Florida, United States, 33024
    • Cancer Care Center of Brevard Palm Bay, Florida, United States, 32909
  • United States, Georgia
    • Northside Hospital Cancer Institute Marietta, Georgia, United States, 30060
  • United States, Indiana
    • Fort Wayne Medical Oncology & Hematology, Inc. Fort Wayne, Indiana, United States, 46804
  • United States, Maryland
    • Maryland Oncology Hematology, P.A. Rockville, Maryland, United States, 20850
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02115
  • United States, Minnesota
    • University of Minnesota Hospital Minneapolis, Minnesota, United States, 55455
  • United States, Missouri
    • Research Medical Center Kansas City, Missouri, United States, 63142
  • United States, Nevada
    • Comprehensive Cancer Centers of Nevada Las Vegas, Nevada, United States, 89169
  • United States, New York
    • New York Oncology Hematology, P.C Albany, New York, United States, 12208
    • Associated Medical Professionals of NY Syracuse, New York, United States, 13210
  • United States, Oregon
    • Northwest Cancer Specialists PC Tigard, Oregon, United States, 97223
  • United States, Tennessee
    • University of Tennessee Medical Center Knoxville, Tennessee, United States, 37920
    • Sarah Cannon Research Institute SCRI Nashville, Tennessee, United States, 37203
  • United States, Texas
    • Texas Oncology Fort Worth Fort Worth, Texas, United States, 76104
    • Texas Oncology-Memorial City Houston, Texas, United States, 77024
    • Texas Oncology - Longview Cancer Center Longview, Texas, United States, 75601
    • Scott & White Memorial Hospital & Clinic Temple, Texas, United States, 76508
    • US Oncology The Woodlands, Texas, United States, 77380
    • Texas Oncology Cancer Care and Research Center Waco, Texas, United States, 76712
  • United States, Utah
    • University of Utah School of Medicine Salt Lake City, Utah, United States, 84132
  • United States, Vermont
    • University of Vermont Medical Center Burlington, Vermont, United States, 05401
  • Australia, New South Wales
    • Chris O'Brien Lifehouse Camperdown, New South Wales, Australia, 2050
    • Southside Cancer Care Centre Kogarah, New South Wales, Australia, 2228
    • Macquarie University Hospital Macquarie Park, New South Wales, Australia, 2109
    • Prince of Wales Hospital Randwick, New South Wales, Australia, 2031
  • Australia, Victoria
    • St Vincents Hospital Melbourne Fitzroy, Victoria, Australia, 3065
  • Denmark,
    • Finsen Institute Copenhagen, , Denmark, 2100
    • Næstved Sygehus Næstved, , Denmark, 4700
  • Germany, Baden-Württemberg
    • Studienpraxis Urologie Nürtingen, Baden-Württemberg, Germany, 72622
  • Germany, Nordrhein-Westfalen
    • Universitätsklinikum Münster Münster, Nordrhein-Westfalen, Germany, 48149
  • Germany,
    • Universitätsklinikum Tübingen Tübingen, , Germany, 72076
  • Korea, Republic of, Korea
    • Samsung Medical Center Seoul, Korea, Korea, Republic of, 06351
  • Korea, Republic of,
    • Seoul National University Hospital Seoul, , Korea, Republic of, 03080
    • Severance Hospital, Yonsei University Health System Seoul, , Korea, Republic of, 03722
    • Asan Medical Center Seoul, , Korea, Republic of, 05505
  • Netherlands, Gelderland
    • Canisius-Wilhelmina Ziekenhuis Nijmegen, Gelderland, Netherlands, 6532 SZ
  • Netherlands, South Holland
    • Erasmus Medisch Centrum Rotterdam, South Holland, Netherlands, 3015 GD
  • Netherlands,
    • St. Antonius Ziekenhuis, locatie Nieuwegein Utrecht, , Netherlands, 3543 AZ
  • Romania, Dolj
    • Centrul de Oncologie Sf. Nectarie SRL Craiova, Dolj, Romania, 200347
  • Romania, Ilfov
    • S.C. R.T.C. Radiology Therapeutic Center S.R.L. Otopeni, Ilfov, Romania, 075100
  • Romania,
    • SC Gral Medical SRL Bucuresti, , Romania, 031422
    • Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta Constanta, , Romania, 900591
  • Spain, Andalucia
    • Hospital Universitario Virgen de la Victoria Malaga, Andalucia, Spain, 29010
  • Spain, Barcelona
    • Institut Catala d'Oncologia L'Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Spain,
    • Hospital Universitari Vall d'Hebron Barcelona, , Spain, 08035
    • Hospital Clinic I Provincial Barcelona, , Spain, 08036
    • Hospital General Universitario Gregorio Marañon Madrid, , Spain, 28007
    • Hospital Universitario Ramón y Cajal Madrid, , Spain, 28034
    • Hospital Universitario 12 de Octubre Madrid, , Spain, 28041
  • United Kingdom, Devon
    • Derriford Hospital Plymouth, Devon, United Kingdom, PL6 8DH
  • United Kingdom, Greater London
    • University College Hospital - London London, Greater London, United Kingdom, NW1 2BU
  • United Kingdom, London
    • Charing Cross Hospital Chelsea, London, United Kingdom, W6 8RF
  • United Kingdom,
    • Northampton General Hospital Northampton, , United Kingdom, NN1 5BD

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03706365
Other Study ID Numbers: I3Y-MC-JPCM
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Eli Lilly and Company:

Metastatic Castration Resistant Prostate Cancer

mCRPC

Additional relevant MeSH terms:

Prostatic Neoplasms

Prednisone

Abiraterone Acetate

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on January 20, 2021