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

Use our guide to learn which trials are right for you!

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
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Matthew Smith
Phone: 617-726-2943
?
mi
from
Boston, MA
Click here to add this to my saved trials
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Principal Investigator: Paul M Swanson
Phone: 772-408-5159
?
mi
from
Port Saint Lucie, FL
Click here to add this to my saved trials
Asheville, North Carolina 28801
Principal Investigator: Christopher H Chay
Phone: 828-253-4262
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Bakersfield, California 93309
Principal Investigator: David Eduardo Kanamori
Phone: 6618627158
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Burlington, Vermont 05405
Principal Investigator: Steven Ades
Phone: 802-444-0000
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Camperdown, New South Wales 2050
Principal Investigator: Lisa Horvath
Phone: 61285140149
?
mi
from
Camperdown,
Click here to add this to my saved trials
Dallas, Texas 75390
Principal Investigator: Kevin Courtney
Phone: 214-648-4180
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Fairhaven, Massachusetts 02719
Principal Investigator: Sonia Seng
Phone: 508-973-7888
?
mi
from
Fairhaven, MA
Click here to add this to my saved trials
Fort Wayne, Indiana 46815
Principal Investigator: Ahad A Sadiq
Phone: 260-484-8830
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Fullerton, California 92835
Principal Investigator: Sanjay Sharma
Phone: 714-446-5810
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Hollywood, Florida 33024
Principal Investigator: Issac Levy
Phone: 954-450-1808
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77024
Principal Investigator: Gurjyot K Doshi
Phone: 281-392-2757
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
Principal Investigator: Mazen Khalil
Phone: 870-207-8177
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
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...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37920
Principal Investigator: Antony Charles
Phone: 865-544-9773
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
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...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
10103 RidgeGate Parkway
Lone Tree, Colorado 80124
Principal Investigator: Robert Jotte
Phone: 303-388-4876
?
mi
from
Lone Tree, CO
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90024
Principal Investigator: SMO TRIO -Translational Research
Phone: 310-794-6500
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
Principal Investigator: Arash R Kalebasty
Phone: 502-629-3102
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Crain Garrot
Phone: 770-590-8311
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
Principal Investigator: Arpit Rao
Phone: 612-301-2180
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Monterey, California 93940
Principal Investigator: Laura Stampleman
Phone: 831-375-4105
?
mi
from
Monterey, CA
Click here to add this to my saved trials
Nashville, Tennessee 37203
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Orlando, Florida 32806
Principal Investigator: Daniel Landau
Phone: 321-841-2285
?
mi
from
Orlando, FL
Click here to add this to my saved trials
625 North 6th Street
Phoenix, Arizona 85013
Principal Investigator: Jue Wang
Phone: 602-827-2680
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona
Principal Investigator: Alan Bryce
Phone: 480-342-2000
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Principal Investigator: Neeraj Agarwal
Phone: 801-213-5658
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Syracuse, New York 13210
Principal Investigator: Christopher Pieczonka
Phone: 315-478-4185
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Temple, Texas 76508
Principal Investigator: Sherronda M Henderson
Phone: 254-724-5918
?
mi
from
Temple, TX
Click here to add this to my saved trials
The Woodlands, Texas 77380
Principal Investigator: SMO US Oncology
Phone: 281-863-1000
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Tucson, Arizona 85724
Principal Investigator: Andrew Kraft
Phone: 520-626-7685
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74146
Principal Investigator: Mark R Olsen
Phone: 918-505-3200
?
mi
from
Tulsa, OK
Click here to add this to my saved trials