Back to resultsA Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer (CYCLONE 2)
Primary Purpose
Prostate Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Abemaciclib
Abiraterone Acetate
Prednisone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Metastatic Castration Resistant Prostate Cancer, mCRPC
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).
Sites / Locations
- The University of Arizona Cancer Center - North Campus
- St. Bernards Medical Center
- CBCC Global Research, Inc.
- TRIO-US (Translational Research in Oncology-US)
- Pacific Cancer Care
- Sansum Clinic_Kendle
- Rocky Mountain Cancer Center
- Millennium Oncology - Hollywood
- USO-Cancer Care Center of Brevard, Inc.
- Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
- Maryland Oncology Hematology - Columbia
- M Health Fairview University of Minnesota Medical Center - East Bank
- Research Medical Center
- Associated Medical Professionals - Urology
- Oklahoma Cancer Specialists and Research Institute, LLC
- Northwest Cancer Specialists PC
- Texas Oncology Fort Worth
- Texas Oncology-Memorial City
- Texas Oncology - Longview Cancer Center
- Baylor Scott & White Medical Center - Temple
- US Oncology
- Texas Oncology Cancer Care and Research Center
- Chris O'Brien Lifehouse
- Southside Cancer Care Centre
- Lanzhou university second hospital
- The First Affiliated Hospital of Henan University of Science &Technology
- Wuhan Union Hospital
- Hunan Provincial People's Hospital
- Hunan Cancer Hospital
- Wuxi People's Hospital
- Yantai Yuhuangding Hospital
- Huashan Hospital Affiliated Fudan University
- Nanchong Central Hospital
- Tianjin Medical University Cancer Institute and Hospital
- The First Affiliated Hospital, Zhejiang University
- Zhejiang Provincial People's Hospital
- Rigshospitalet
- Centre de Cancérologie du Grand Montpellier
- Centre Leon Berard
- CHU de Bordeaux Hop St ANDRE
- Studienpraxis Urologie
- Universitaetsklinikum Tuebingen
- Gesundheitszentrum Holzminden
- Studienzentrum Bayenthal Urologische Partnerschaft Köln
- Urologie Neandertal - Praxis Mettmann
- Private Practice - Dr. Stammel & Dr. Garcia
- Private Practice - Dr. Ralf Eckert
- Private Practice - Dr. Silvio Szymula
- Japanese Red Cross Nagoya Daini Hospital
- Hirosaki University Hospital
- Toho University Sakura Medical Center
- Hokkaido University Hospital
- Kobe City Medical Center General Hospital
- Kanazawa University Hospital
- Yokohama City University Medical Center
- Saitama Prefectural Cancer Center
- Hamamatsu University Hospital
- Showa University Hospital
- Gifu University Hospital
- National Hospital Organization Kumamoto Medical Center
- Osaka International Cancer Institute
- Samsung Medical Center
- Canisius-Wilhelmina Ziekenhuis
- Erasmus Medisch Centrum
- Hospital Universitario Virgen de la Victoria
- Derriford Hospital
- Charing Cross Hospital
- University College London Hospital
- Northampton General Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Experimental
Active Comparator
Arm Label
A1. Abiraterone plus Prednisone and Abemaciclib
A2. Abiraterone plus Prednisone and Abemaciclib
B1. Abiraterone plus Prednisone and Placebo
B2. Abiraterone plus Prednisone and Placebo
A. Abiraterone plus Prednisone and Abemaciclib
B. Abiraterone plus Prednisone and Placebo
Arm Description
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Abiraterone plus prednisone administered orally and placebo administered orally.
Abiraterone plus prednisone administered orally and placebo administered orally.
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Abiraterone plus prednisone administered orally and placebo administered orally.
Outcomes
Primary Outcome Measures
Radiographic Progression Free Survival (rPFS)
rPFS by investigator assessment
Secondary Outcome Measures
Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression
Radiographic Progression Free Survival (rPFS)
rPFS by blinded, independent, central review
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
ORR: Percentage of participants with a CR or PR
Duration of Response (DOR)
DOR
Overall Survival (OS)
OS
Time to Symptomatic Progression
Time to symptomatic progression
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
PK: Mean steady state exposure of abemaciclib
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
PK: Mean steady state exposure of abemaciclib metabolite LSN2839567
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
PK: Mean Steady State Exposure of Abiraterone Acetate
PK: Mean Steady State Exposure of Abiraterone Acetate
Time to Worst Pain Progression
Measured by the Worst Pain Numeric Rating Scale (NRS) and World Health Organization-Analgesic Ladder (WHO-AL). NRS score measures worst pain over the last 24 hours on a 0 to 10-point NRS, where 0 -s "no pain" and 10 is "pain as bad as you can imagine. The WHO-AL classifies analgesic use into four categories, where 1 = no analgesic and 4 = strong opioids.
Full Information
NCT ID
NCT03706365
First Posted
September 18, 2018
Last Updated
October 20, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT03706365
Brief Title
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
Acronym
CYCLONE 2
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
November 14, 2023 (Anticipated)
Study Completion Date
June 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Metastatic Castration Resistant Prostate Cancer, mCRPC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A1. Abiraterone plus Prednisone and Abemaciclib
Arm Type
Experimental
Arm Description
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Arm Title
A2. Abiraterone plus Prednisone and Abemaciclib
Arm Type
Experimental
Arm Description
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Arm Title
B1. Abiraterone plus Prednisone and Placebo
Arm Type
Active Comparator
Arm Description
Abiraterone plus prednisone administered orally and placebo administered orally.
Arm Title
B2. Abiraterone plus Prednisone and Placebo
Arm Type
Active Comparator
Arm Description
Abiraterone plus prednisone administered orally and placebo administered orally.
Arm Title
A. Abiraterone plus Prednisone and Abemaciclib
Arm Type
Experimental
Arm Description
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Arm Title
B. Abiraterone plus Prednisone and Placebo
Arm Type
Active Comparator
Arm Description
Abiraterone plus prednisone administered orally and placebo administered orally.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
LY2835219
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Abiraterone Acetate
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Radiographic Progression Free Survival (rPFS)
Description
rPFS by investigator assessment
Time Frame
Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Secondary Outcome Measure Information:
Title
Time to Prostate-Specific Antigen (PSA) Progression
Description
Time to PSA progression
Time Frame
Baseline to the Date of the First Observation of PSA Progression (Estimated up to 21 Months)
Title
Radiographic Progression Free Survival (rPFS)
Description
rPFS by blinded, independent, central review
Time Frame
Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Title
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
Description
ORR: Percentage of participants with a CR or PR
Time Frame
Baseline to Radiographic Disease Progression (Estimated up to 21 Months)
Title
Duration of Response (DOR)
Description
DOR
Time Frame
Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Title
Overall Survival (OS)
Description
OS
Time Frame
Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months)
Title
Time to Symptomatic Progression
Description
Time to symptomatic progression
Time Frame
Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months)
Title
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Description
PK: Mean steady state exposure of abemaciclib
Time Frame
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Title
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Description
PK: Mean steady state exposure of abemaciclib metabolite LSN2839567
Time Frame
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Title
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Description
PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
Time Frame
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Title
PK: Mean Steady State Exposure of Abiraterone Acetate
Description
PK: Mean Steady State Exposure of Abiraterone Acetate
Time Frame
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Title
Time to Worst Pain Progression
Description
Measured by the Worst Pain Numeric Rating Scale (NRS) and World Health Organization-Analgesic Ladder (WHO-AL). NRS score measures worst pain over the last 24 hours on a 0 to 10-point NRS, where 0 -s "no pain" and 10 is "pain as bad as you can imagine. The WHO-AL classifies analgesic use into four categories, where 1 = no analgesic and 4 = strong opioids.
Time Frame
Baseline through follow-up (Estimated up to 21 months)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
The University of Arizona Cancer Center - North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
St. Bernards Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
CBCC Global Research, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
TRIO-US (Translational Research in Oncology-US)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Sansum Clinic_Kendle
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Millennium Oncology - Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
USO-Cancer Care Center of Brevard, Inc.
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32909
Country
United States
Facility Name
Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Maryland Oncology Hematology - Columbia
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
M Health Fairview University of Minnesota Medical Center - East Bank
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
63142
Country
United States
Facility Name
Associated Medical Professionals - Urology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Northwest Cancer Specialists PC
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Texas Oncology Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology-Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology - Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Baylor Scott & White Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
US Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Texas Oncology Cancer Care and Research Center
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Southside Cancer Care Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2228
Country
Australia
Facility Name
Lanzhou university second hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hunan Provincial People's Hospital
City
ChangSha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264099
Country
China
Facility Name
Huashan Hospital Affiliated Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Nanchong Central Hospital
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Centre de Cancérologie du Grand Montpellier
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34070
Country
France
Facility Name
Centre Leon Berard
City
Lyon CEDEX 08
State/Province
Rhône-Alpes
ZIP/Postal Code
69373
Country
France
Facility Name
CHU de Bordeaux Hop St ANDRE
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Studienpraxis Urologie
City
Nürtingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72622
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Gesundheitszentrum Holzminden
City
Holzminden
State/Province
Niedersachsen
ZIP/Postal Code
37603
Country
Germany
Facility Name
Studienzentrum Bayenthal Urologische Partnerschaft Köln
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50968
Country
Germany
Facility Name
Urologie Neandertal - Praxis Mettmann
City
Mettmann
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40822
Country
Germany
Facility Name
Private Practice - Dr. Stammel & Dr. Garcia
City
Wesel
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46483
Country
Germany
Facility Name
Private Practice - Dr. Ralf Eckert
City
Lutherstadt Eisleben
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06295
Country
Germany
Facility Name
Private Practice - Dr. Silvio Szymula
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
4105
Country
Germany
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-0841
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Saitama Prefectural Cancer Center
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-8555
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
ZIP/Postal Code
501-1112
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Derriford Hospital
City
Plymouth
State/Province
Devon
ZIP/Postal Code
Pl6 8DH
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
Hammersmith And Fulham
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
University College London Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Northampton General Hospital NHS Trust
City
Northampton
State/Province
Northamptonshire
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3gu4aah7luigAwcweY4wWK
Description
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
Learn more about this trial
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
We'll reach out to this number within 24 hrs