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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
Date last updated
20/04/2025

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 - Placebo
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Prednisone

Experimental: Abemaciclib - Participants received 200 milligrams (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Placebo comparator: Placebo - Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.


Treatment: Drugs: Abemaciclib
Administered orally.

Treatment: Drugs: Placebo
Administered orally.

Treatment: Drugs: Abiraterone acetate
Administered orally.

Treatment: Drugs: Prednisone
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)
Assessment method [1] 0 0
The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.
Timepoint [1] 0 0
From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
Secondary outcome [1] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Assessment method [1] 0 0
The PSA progression is defined as a greater than or equal to (\>=) 25 percentage (%) increase and an absolute increase of \>=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later.
Timepoint [1] 0 0
From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)
Secondary outcome [2] 0 0
Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review
Assessment method [2] 0 0
rPFS is defined as the time from the date of randomization to the earliest date of radiographic disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
Timepoint [2] 0 0
From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
Secondary outcome [3] 0 0
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Assessment method [3] 0 0
ORR is a summary measure of best overall response (BOR) as defined by RECIST 1.1 for soft tissue per investigator assessment. BOR is derived from time point responses. All time point responses observed while on study treatment and during the short-term follow-up period (but before the initiation of post-discontinuation systemic anticancer therapy) will be included in the derivation. Each patient's BOR will be categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). A BOR of CR or PR will require confirmation, but sensitivity analyses of response-based endpoints may be performed where confirmation of a BOR of CR or PR is not required.
Timepoint [3] 0 0
Baseline to Radiographic Disease Progression (Up to 60 Months)
Secondary outcome [4] 0 0
Duration of Response (DOR)
Assessment method [4] 0 0
The DoR time is defined only for responders (participants with a soft tissue BOR of CR or PR) in the measurable disease population. It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator determined radiographic disease progression or death from any cause, whichever is earlier.
Timepoint [4] 0 0
Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
Secondary outcome [5] 0 0
Overall Survival (OS)
Assessment method [5] 0 0
The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive.
Timepoint [5] 0 0
From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)
Secondary outcome [6] 0 0
Time to Symptomatic Progression
Assessment method [6] 0 0
Time to symptomatic progression is defined as the time from randomization to any of the following (whichever occurs earlier): 1. Symptomatic Skeletal Event (SSE), defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression. 2. Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy. 3. Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
Timepoint [6] 0 0
From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months)
Secondary outcome [7] 0 0
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Assessment method [7] 0 0
PK: Mean steady state exposure of abemaciclib.
Timepoint [7] 0 0
Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
Secondary outcome [8] 0 0
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Assessment method [8] 0 0
PK: Mean steady state exposure of abemaciclib metabolite LSN2839567.
Timepoint [8] 0 0
C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
Secondary outcome [9] 0 0
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Assessment method [9] 0 0
PK: Mean steady state exposure of abemaciclib metabolite LSN3106726.
Timepoint [9] 0 0
C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
Secondary outcome [10] 0 0
PK: Mean Steady State Exposure of Abiraterone Acetate
Assessment method [10] 0 0
PK: Mean Steady State Exposure of Abiraterone Acetate.
Timepoint [10] 0 0
C1 D15, Post dose
Secondary outcome [11] 0 0
Time to Worst Pain Progression
Assessment method [11] 0 0
Time to Worst Pain Progression defined as the time from randomization to any of the following (whichever occurs earlier): For participants without opioid use at baseline (World Health Organization-Analgesic Ladder-WHO-AL = 2):- Worst pain progression (an increase of 2 points from baseline on the Worst Pain Numeric Rating Scale (NRS) item on 2 consecutive evaluations), Initiation of weak or strong opioids (WHO-AL = 3); For participants with weak or strong opioid use at baseline (WHO-AL = 3): Worst pain progression (an increase of 2 points from baseline on the Worst Pain NRS item on 2 consecutive evaluations) without concurrent decreased opioid use (a decrease in WHO-AL of 1 or more) -Increased opioid use (an increase in WHO-AL of 1 or more).
Timepoint [11] 0 0
From Randomization Through Follow-up (Up to 60 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
Accrual to date
Final
393
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
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
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
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Vermont
Country [16] 0 0
China
State/province [16] 0 0
Anhui
Country [17] 0 0
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
Country [21] 0 0
China
State/province [21] 0 0
Hubei
Country [22] 0 0
China
State/province [22] 0 0
Hunan
Country [23] 0 0
China
State/province [23] 0 0
Jiangsu
Country [24] 0 0
China
State/province [24] 0 0
Jiangxi
Country [25] 0 0
China
State/province [25] 0 0
Jilin
Country [26] 0 0
China
State/province [26] 0 0
Shaanxi
Country [27] 0 0
China
State/province [27] 0 0
Shandong
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Sichuan
Country [30] 0 0
China
State/province [30] 0 0
Tianjin
Country [31] 0 0
China
State/province [31] 0 0
Xinjiang
Country [32] 0 0
China
State/province [32] 0 0
Zhejiang
Country [33] 0 0
Denmark
State/province [33] 0 0
Hovedstaden
Country [34] 0 0
Denmark
State/province [34] 0 0
Sjælland
Country [35] 0 0
France
State/province [35] 0 0
Languedoc-Roussillon
Country [36] 0 0
France
State/province [36] 0 0
Pays-de-la-Loire
Country [37] 0 0
France
State/province [37] 0 0
Rhône-Alpes
Country [38] 0 0
France
State/province [38] 0 0
Vendée
Country [39] 0 0
France
State/province [39] 0 0
Bordeaux
Country [40] 0 0
France
State/province [40] 0 0
Île-de-France
Country [41] 0 0
Germany
State/province [41] 0 0
Baden-Württemberg
Country [42] 0 0
Germany
State/province [42] 0 0
Niedersachsen
Country [43] 0 0
Germany
State/province [43] 0 0
Nordrhein-Westfalen
Country [44] 0 0
Germany
State/province [44] 0 0
Sachsen-Anhalt
Country [45] 0 0
Germany
State/province [45] 0 0
Sachsen
Country [46] 0 0
Japan
State/province [46] 0 0
Aichi
Country [47] 0 0
Japan
State/province [47] 0 0
Aomori
Country [48] 0 0
Japan
State/province [48] 0 0
Chiba
Country [49] 0 0
Japan
State/province [49] 0 0
Hokkaido
Country [50] 0 0
Japan
State/province [50] 0 0
Hyogo
Country [51] 0 0
Japan
State/province [51] 0 0
Ishikawa
Country [52] 0 0
Japan
State/province [52] 0 0
Kanagawa
Country [53] 0 0
Japan
State/province [53] 0 0
Saitama
Country [54] 0 0
Japan
State/province [54] 0 0
Shizuoka
Country [55] 0 0
Japan
State/province [55] 0 0
Tokyo
Country [56] 0 0
Japan
State/province [56] 0 0
Gifu
Country [57] 0 0
Japan
State/province [57] 0 0
Kumamoto
Country [58] 0 0
Japan
State/province [58] 0 0
Osaka
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul-teukbyeolsi [Seoul]
Country [60] 0 0
Netherlands
State/province [60] 0 0
Gelderland
Country [61] 0 0
Netherlands
State/province [61] 0 0
Zuid-Holland
Country [62] 0 0
Netherlands
State/province [62] 0 0
Utrecht
Country [63] 0 0
Romania
State/province [63] 0 0
Constan?a
Country [64] 0 0
Romania
State/province [64] 0 0
Dolj
Country [65] 0 0
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03706365