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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03706365




Registration number
NCT03706365
Ethics application status
Date submitted
18/09/2018
Date registered
16/10/2018

Titles & IDs
Public title
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
Scientific 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
Secondary ID [1] 0 0
I3Y-MC-JPCM
Secondary ID [2] 0 0
16598
Universal Trial Number (UTN)
Trial acronym
CYCLONE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo

Experimental: A1. Abiraterone plus Prednisone and Abemaciclib - Abiraterone plus prednisone administered orally and abemaciclib administered orally.

Experimental: A2. Abiraterone plus Prednisone and Abemaciclib - Abiraterone plus prednisone administered orally and abemaciclib administered orally.

Active comparator: B1. Abiraterone plus Prednisone and Placebo - Abiraterone plus prednisone administered orally and placebo administered orally.

Active comparator: B2. Abiraterone plus Prednisone and Placebo - Abiraterone plus prednisone administered orally and placebo administered orally.

Experimental: A. Abiraterone plus Prednisone and Abemaciclib - Abiraterone plus prednisone administered orally and abemaciclib administered orally.

Active comparator: B. Abiraterone plus Prednisone and Placebo - Abiraterone plus prednisone administered orally and placebo administered orally.


Treatment: Drugs: Abemaciclib
Administered orally.

Treatment: Drugs: Abiraterone Acetate
Administered orally.

Treatment: Drugs: Prednisone
Administered orally.

Treatment: Drugs: Placebo
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression Free Survival (rPFS)
Timepoint [1] 0 0
Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Secondary outcome [1] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [1] 0 0
Baseline to the Date of the First Observation of PSA Progression (Estimated up to 21 Months)
Secondary outcome [2] 0 0
Radiographic Progression Free Survival (rPFS)
Timepoint [2] 0 0
Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Secondary outcome [3] 0 0
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
Timepoint [3] 0 0
Baseline to Radiographic Disease Progression (Estimated up to 21 Months)
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months)
Secondary outcome [6] 0 0
Time to Symptomatic Progression
Timepoint [6] 0 0
Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months)
Secondary outcome [7] 0 0
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Timepoint [7] 0 0
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary outcome [8] 0 0
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Timepoint [8] 0 0
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary outcome [9] 0 0
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Timepoint [9] 0 0
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary outcome [10] 0 0
PK: Mean Steady State Exposure of Abiraterone Acetate
Timepoint [10] 0 0
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary outcome [11] 0 0
Time to Worst Pain Progression
Timepoint [11] 0 0
Baseline through follow-up (Estimated up to 21 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Southside Cancer Care Centre - Kogarah
Recruitment hospital [3] 0 0
Macquarie University - Macquarie University
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2228 - Kogarah
Recruitment postcode(s) [3] 0 0
2109 - Macquarie University
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
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California
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United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
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Indiana
Country [8] 0 0
United States of America
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Massachusetts
Country [9] 0 0
United States of America
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Minnesota
Country [10] 0 0
United States of America
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Nevada
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United States of America
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New York
Country [12] 0 0
United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Vermont
Country [16] 0 0
China
State/province [16] 0 0
Anhui
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China
State/province [17] 0 0
Gansu
Country [18] 0 0
China
State/province [18] 0 0
Guangdong
Country [19] 0 0
China
State/province [19] 0 0
Heilongjiang
Country [20] 0 0
China
State/province [20] 0 0
Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Shaanxi
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China
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China
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Shanghai
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China
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Sichuan
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China
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Tianjin
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China
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Xinjiang
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China
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Zhejiang
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Denmark
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Hovedstaden
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Denmark
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Sjælland
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France
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Languedoc-Roussillon
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France
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Pays-de-la-Loire
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France
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Rhône-Alpes
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France
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Vendée
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France
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Bordeaux
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France
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Île-de-France
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Germany
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Baden-Württemberg
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Japan
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Aichi
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Gifu
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Japan
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Kumamoto
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Japan
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Osaka
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Netherlands
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Gelderland
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Netherlands
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Zuid-Holland
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Netherlands
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Utrecht
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Romania
State/province [63] 0 0
Constan?a
Country [64] 0 0
Romania
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Dolj
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Romania
State/province [65] 0 0
Bucure?ti
Country [66] 0 0
Spain
State/province [66] 0 0
Barcelona [Barcelona]
Country [67] 0 0
Spain
State/province [67] 0 0
Catalunya [Cataluña]
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid, Comunidad De
Country [69] 0 0
Spain
State/province [69] 0 0
Málaga
Country [70] 0 0
Spain
State/province [70] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03706365