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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:November 27, 2018
End Date:February 14, 2024
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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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

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.


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).
We found this trial at
34
sites
10103 RidgeGate Parkway
Lone Tree, Colorado 80124
Principal Investigator: Robert Jotte
Phone: 303-388-4876
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Matthew Smith
Phone: 617-726-2943
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Principal Investigator: Paul M Swanson
Phone: 772-408-5159
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Asheville, North Carolina 28801
Principal Investigator: Christopher H Chay
Phone: 828-253-4262
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Bakersfield, California 93309
Principal Investigator: David Eduardo Kanamori
Phone: 6618627158
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Burlington, Vermont 05405
Principal Investigator: Steven Ades
Phone: 802-444-0000
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Camperdown, New South Wales 2050
Principal Investigator: Lisa Horvath
Phone: 61285140149
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Dallas, Texas 75390
Principal Investigator: Kevin Courtney
Phone: 214-648-4180
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Fairhaven, Massachusetts 02719
Principal Investigator: Sonia Seng
Phone: 508-973-7888
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Fort Wayne, Indiana 46815
Principal Investigator: Ahad A Sadiq
Phone: 260-484-8830
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Fullerton, California 92835
Principal Investigator: Sanjay Sharma
Phone: 714-446-5810
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Hollywood, Florida 33024
Principal Investigator: Issac Levy
Phone: 954-450-1808
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Houston, Texas 77024
Principal Investigator: Gurjyot K Doshi
Phone: 281-392-2757
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Jonesboro, Arkansas 72401
Principal Investigator: Mazen Khalil
Phone: 870-207-8177
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Principal Investigator: Peter J Van Veldhuizen
Phone: 816-276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Knoxville, Tennessee 37920
Principal Investigator: Antony Charles
Phone: 865-544-9773
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Rana McKay
Phone: 858-534-7600
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Alexandra Drakaki
Phone: 310-829-5471
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, California 90024
Principal Investigator: SMO TRIO -Translational Research
Phone: 310-794-6500
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Louisville, Kentucky 40207
Principal Investigator: Arash R Kalebasty
Phone: 502-629-3102
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Marietta, Georgia 30060
Principal Investigator: Crain Garrot
Phone: 770-590-8311
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Minneapolis, Minnesota 55455
Principal Investigator: Arpit Rao
Phone: 612-301-2180
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Monterey, California 93940
Principal Investigator: Laura Stampleman
Phone: 831-375-4105
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Nashville, Tennessee 37203
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Daniel P. Petrylak
Phone: 203-200-4822
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Orlando, Florida 32806
Principal Investigator: Daniel Landau
Phone: 321-841-2285
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625 North 6th Street
Phoenix, Arizona 85013
Principal Investigator: Jue Wang
Phone: 602-827-2680
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Phoenix, Arizona
Principal Investigator: Alan Bryce
Phone: 480-342-2000
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Salt Lake City, Utah 84132
Principal Investigator: Neeraj Agarwal
Phone: 801-213-5658
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Syracuse, New York 13210
Principal Investigator: Christopher Pieczonka
Phone: 315-478-4185
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Temple, Texas 76508
Principal Investigator: Sherronda M Henderson
Phone: 254-724-5918
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The Woodlands, Texas 77380
Principal Investigator: SMO US Oncology
Phone: 281-863-1000
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Tucson, Arizona 85724
Principal Investigator: Andrew Kraft
Phone: 520-626-7685
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Tulsa, Oklahoma 74146
Principal Investigator: Mark R Olsen
Phone: 918-505-3200
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