Clinical trial NCT03706365: A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Metastatic Castration Resistant Prostate Cancer
mCRPC
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 393
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Radiographic Progression Free Survival (rPFS)
timeFrame: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
Secondary outcomes:
measure: Time to Prostate-Specific Antigen (PSA) Progression
timeFrame: From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)
measure: Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review
timeFrame: From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
measure: Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline to Radiographic Disease Progression (Up to 60 Months)
measure: Duration of Response (DOR)
timeFrame: Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
measure: Overall Survival (OS)
timeFrame: From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)
measure: Time to Symptomatic Progression
timeFrame: From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months)
measure: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
timeFrame: Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
measure: PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
timeFrame: C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
measure: PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
timeFrame: C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
measure: PK: Mean Steady State Exposure of Abiraterone Acetate
timeFrame: C1 D15, Post dose
measure: Time to Worst Pain Progression
timeFrame: From Randomization Through Follow-up (Up to 60 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Center - North Campus
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc.
state: California
city: Fullerton
country: United States
facility: Providence St. Jude Medical Center
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: TRIO-US (Translational Research in Oncology-US)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 100)
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic_Kendle
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Hollywood
country: United States
facility: Millennium Oncology - Hollywood
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - East Bank
state: Minnesota
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals - Urology
state: New York
city: Nashville
country: United States
facility: Research Medical Center
state: Tennessee
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: The Woodlands
country: United States
facility: New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Northwest Cancer Specialists PC
state: Texas
city: The Woodlands
country: United States
facility: Sansum Clinic_Kendle
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Longview Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology Cancer Care and Research Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology Fort Worth
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: The Woodlands
country: United States
facility: USO-Cancer Care Center of Brevard, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center Inc.
state: Vermont
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Kogarah
country: Australia
facility: Southside Cancer Care Centre
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: Wannan Medical College Yijishan Hospital
state: Anhui
city: Lanzhou
country: China
facility: Lanzhou university second hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Centre
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology
state: Hubei
city: ChangSha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated Fudan University
state: Shanghai
city: Nanchong
country: China
facility: Nanchong Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Hovedstaden
city: Næstved
country: Denmark
facility: Næstved Sygehus
state: Sjælland
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier
state: Languedoc-Roussillon
city: Le Mans
country: France
facility: Clinique Victor Hugo Le Mans
state: Pays-de-la-Loire
city: Lyon CEDEX 08
country: France
facility: Centre Leon Berard
state: Rhône-Alpes
city: La Roche-sur-Yon
country: France
facility: CHD Vendee
state: Vendée
city: Bordeaux
country: France
facility: CHU de Bordeaux Hop St ANDRE
city: Créteil
country: France
facility: Henri Mondor Hospital
state: Île-de-France
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-Württemberg
city: Holzminden
country: Germany
facility: Gesundheitszentrum Holzminden
state: Niedersachsen
city: Cologne
country: Germany
facility: Studienzentrum Bayenthal Urologische Partnerschaft Köln
state: Nordrhein-Westfalen
city: Mettmann
country: Germany
facility: Urologie Neandertal - Praxis Mettmann
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus
state: Nordrhein-Westfalen
city: Wesel
country: Germany
facility: Private Practice - Dr. Stammel & Dr. Garcia
state: Nordrhein-Westfalen
city: Lutherstadt Eisleben
country: Germany
facility: Private Practice - Dr. Ralf Eckert
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Private Practice - Dr. Silvio Szymula
state: Sachsen
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Ina-machi
country: Japan
facility: Saitama Prefectural Cancer Center
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Shinagawa
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
state: Gelderland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: St. Antonius Ziekenhuis, locatie Utrecht
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital OCH
state: Constanța
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"
state: Dolj
city: București
country: Romania
facility: Gral Medical Diagnostic Center
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Hospitalet
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad De
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Málaga
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: