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

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

Status

Closed

Cancer Type

Bone Tumor

Trial Phase

Phase II
Phase III

Eligibility

18 Years and older, Male

Study Type

Treatment

NCT ID

NCT03706365

Protocol IDs

16598 (primary)
NCI-2019-00897
I3Y-MC-JPCM
2016-004276-21

Study Sponsor

Eli Lilly and Company

NCI Full Details

http://clinicaltrials.gov/show/NCT03706365

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

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.

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta

3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com

Doctors:

Silpa C. Reddy MD
Sreekanth C. Reddy MD
Ronald G. Steis MD

Atlanta Cancer Care - Conyers

1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Cumming

1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041
www.atlantacancercare.com

Doctors:

Sreekanth C. Reddy MD
Ronald G. Steis MD
Amelia B. Zelnak MD
Kelly A. May MD

Atlanta Cancer Care - Decatur

2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge

7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Atlanta Cancer Care - Tower

5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Doctors:

Silpa C. Reddy MD
Sreekanth C. Reddy MD
Amelia B. Zelnak MD
Kelly A. May MD

Georgia Cancer Specialists - Athens

125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com

Doctors:

Ranjana S. Bhargava MD
Priya Rudolph

Georgia Cancer Specialists - Canton

228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Doctors:

Louis Crain Garrot MD
Gena H. Volas-Redd MD
Lynn M. Zemsky MD

Georgia Cancer Specialists - CenterPointe

1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Kennestone

790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com

Doctors:

Louis Crain Garrot MD
Gena H. Volas-Redd MD
Lynn M. Zemsky MD

Georgia Cancer Specialists - Macon-Coliseum

308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD
Premila Malhotra MD

Georgia Cancer Specialists - Stemmer

2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com

Doctors:

Jayanthi Srinivasiah MD
Simbo O. Aduloju MD
Aaron R. Alizadeh MD
Kathleen E. Lambert MD

Northside Hospital Cancer Institute

1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Study Coordinator:
404-303-3355

Doctors:

Rodolfo E. Bordoni MD
Louis Crain Garrot MD
Pradeep C. Jolly MD
Cheryl F. Jones MD
Gurinderjit K. Sidhu MD
Gena H. Volas-Redd MD
Amelia B. Zelnak MD
Simbo O. Aduloju MD
Premila Malhotra MD
Aaron R. Alizadeh MD
Kelly A. May MD
Ranjana S. Bhargava MD
Priya Rudolph
Kathleen E. Lambert MD
Tatyana Sklyar

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