The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03706365
Ethics application status
Date submitted
18/09/2018
Date registered
16/10/2018
Date last updated
18/06/2020

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, 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) - rPFS
Timepoint [1] 0 0
Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Primary outcome [2] 0 0
Time to Prostate-Specific Antigen (PSA) Progression - Time to PSA progression
Timepoint [2] 0 0
Baseline to the Date of the First Observation of PSA Progression (Estimated up to 21 Months)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline to Radiographic Disease Progression (Estimated up to 21 Months)
Secondary outcome [2] 0 0
Duration of Response (DOR) - DOR
Timepoint [2] 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 [3] 0 0
Overall Survival (OS) - OS
Timepoint [3] 0 0
Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months)
Secondary outcome [4] 0 0
Time to Symptomatic Progression - Time to symptomatic progression
Timepoint [4] 0 0
Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months)
Secondary outcome [5] 0 0
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib - PK: Mean steady state exposure of abemaciclib
Timepoint [5] 0 0
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary outcome [6] 0 0
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 - PK: Mean steady state exposure of abemaciclib metabolite LSN2839567
Timepoint [6] 0 0
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary outcome [7] 0 0
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 - PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
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 Abiraterone Acetate - PK: Mean Steady State Exposure of Abiraterone Acetate
Timepoint [8] 0 0
Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)

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

- Be able and willing to undergo mandatory tumor biopsy of at least one metastatic site.

- Have adequate organ function.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Minimum age
18 Years
Maximum age
No limit
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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 Hospital - Macquarie Park
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2228 - Kogarah
Recruitment postcode(s) [3] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
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
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Vermont
Country [21] 0 0
Denmark
State/province [21] 0 0
Copenhagen
Country [22] 0 0
Denmark
State/province [22] 0 0
Næstved
Country [23] 0 0
Germany
State/province [23] 0 0
Baden-Württemberg
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein-Westfalen
Country [25] 0 0
Germany
State/province [25] 0 0
Tübingen
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Korea
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Netherlands
State/province [28] 0 0
Gelderland
Country [29] 0 0
Netherlands
State/province [29] 0 0
South Holland
Country [30] 0 0
Netherlands
State/province [30] 0 0
Utrecht
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
Bayamon
Country [32] 0 0
Romania
State/province [32] 0 0
Dolj
Country [33] 0 0
Romania
State/province [33] 0 0
Ilfov
Country [34] 0 0
Romania
State/province [34] 0 0
Bucuresti
Country [35] 0 0
Romania
State/province [35] 0 0
Constanta
Country [36] 0 0
Spain
State/province [36] 0 0
Andalucia
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Devon
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Greater London
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Northampton

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03706365
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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03706365