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 | 
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.
			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
	
								Orlando, Florida 32806			
	
			
					Principal Investigator: Daniel Landau
			
						
										Phone: 321-841-2285
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									185 Cambridge Street
Boston, Massachusetts 02114
	
			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
	
			
					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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								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
	
			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
	
			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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									10103 RidgeGate Parkway
Lone Tree, Colorado 80124
	
			
					Lone Tree, Colorado 80124
Principal Investigator: Robert Jotte
			
						
										Phone: 303-388-4876
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									757 Westwood Plaza
Los Angeles, California 90024
	
			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
	
			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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									625 North 6th Street
Phoenix, Arizona 85013
	
			
					Phoenix, Arizona 85013
Principal Investigator: Jue Wang
			
						
										Phone: 602-827-2680
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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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								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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