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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05288166




Registration number
NCT05288166
Ethics application status
Date submitted
10/03/2022
Date registered
21/03/2022

Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
Scientific title
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Secondary ID [1] 0 0
I3Y-MC-JPEG
Secondary ID [2] 0 0
18448
Universal Trial Number (UTN)
Trial acronym
CYCLONE 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Neoplasm Metastasis 0 0
Urogenital Neoplasms 0 0
Physiological Effects of Drugs 0 0
Antineoplastic Agents 0 0
Antineoplastic Agents, Hormonal 0 0
Androgens 0 0
Hormones 0 0
Hormones, Hormone Substitutes, and Hormone Antagonists 0 0
Abiraterone Acetate 0 0
Steroid Synthesis Inhibitors 0 0
Cytochrome P-450 0 0
Enzyme Inhibitors 0 0
Prednisone 0 0
Prednisolone 0 0
Cyclin-Dependent Kinase 4 0 0
Cyclin-Dependent Kinase 6 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Other cancer types
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Allergies

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

Experimental: Abemaciclib + Abiraterone + Prednisone/Prednisolone - Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.

Active comparator: Placebo + Abiraterone + Prednisone/Prednisolone - Placebo + abiraterone + prednisone/prednisolone administered orally.


Treatment: Drugs: Abemaciclib
Administered orally.

Treatment: Drugs: Abiraterone
Administered orally.

Treatment: Drugs: Prednisone or Prednisolone
Administered orally.

Treatment: Drugs: Placebo for Abemaciclib
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) Assessed by Investigator
Timepoint [1] 0 0
Randomization to radiographic progression or death from any cause (approximately 48 months)
Secondary outcome [1] 0 0
rPFS Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Randomization to radiographic progression or death from any cause (approximately 48 months)
Secondary outcome [2] 0 0
Castration-resistant Prostate Cancer (CRPC)-free Survival
Timepoint [2] 0 0
Randomization to the earliest date of PSA or radiographic progression with a testosterone level of =50 nanogram/deciliter (ng/dL); or death from any cause (approximately 48 months)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Baseline to date of death due to any cause (approximately 60 months)
Secondary outcome [4] 0 0
Time to Pain Progression
Timepoint [4] 0 0
Randomization to pain progression (approximately 48 months)
Secondary outcome [5] 0 0
Time to Deterioration in Health-Related Quality of Life (HRQoL)
Timepoint [5] 0 0
Randomization to the date of HRQoL deterioration (approximately 48 Months)
Secondary outcome [6] 0 0
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Timepoint [6] 0 0
Postdose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)

Eligibility
Key inclusion criteria
* Adenocarcinoma of the prostate (as the predominant histology)
* High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:

* Greater than or equal to (=)4 bone metastases by bone scan and/or
* =1 visceral metastases by computed tomography or magnetic resonance imaging
* Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 & 6) inhibitor
* Development of metastatic prostate cancer in the context of castrate levels of testosterone
* Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
* Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
* History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
* Uncontrolled hypertension
* Clinically active or chronic liver disease, moderate/severe hepatic impairment
* Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization

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 3
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
14/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [3] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Macquarie University - Macquarie University
Recruitment hospital [6] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [7] 0 0
Tasman Oncology Research - Southport
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [10] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [11] 0 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [12] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [13] 0 0
Monash Health - Clayton
Recruitment hospital [14] 0 0
Barwon Health - Geelong
Recruitment hospital [15] 0 0
Austin Health - Heidelberg
Recruitment hospital [16] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [17] 0 0
Epworth Freemasons - Richmond
Recruitment hospital [18] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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2450 - Coffs Harbour
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2010 - Darlinghurst
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2170 - Liverpool
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2109 - Macquarie University
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4101 - South Brisbane
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4215 - Southport
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4102 - Woolloongabba
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5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment postcode(s) [12] 0 0
3128 - Box Hill
Recruitment postcode(s) [13] 0 0
3168 - Clayton
Recruitment postcode(s) [14] 0 0
3220 - Geelong
Recruitment postcode(s) [15] 0 0
3084 - Heidelberg
Recruitment postcode(s) [16] 0 0
3065 - Melbourne
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3121 - Richmond
Recruitment postcode(s) [18] 0 0
6150 - Murdoch
Recruitment outside Australia
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London, City Of

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 European Union (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/NCT05288166