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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
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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
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Secondary ID [1]
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I3Y-MC-JPCM
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Secondary ID [2]
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16598
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Universal Trial Number (UTN)
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Trial acronym
CYCLONE 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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0
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Prostate
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Intervention/exposure
Study type
Interventional(has expanded access)
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic Progression Free Survival (rPFS)
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Assessment method [1]
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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.
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Timepoint [1]
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From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
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Secondary outcome [1]
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Time to Prostate-Specific Antigen (PSA) Progression
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Assessment method [1]
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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.
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Timepoint [1]
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From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)
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Secondary outcome [2]
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Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review
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Assessment method [2]
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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.
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Timepoint [2]
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From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
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Secondary outcome [3]
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Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to Radiographic Disease Progression (Up to 60 Months)
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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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.
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Timepoint [4]
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Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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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.
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Timepoint [5]
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From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)
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Secondary outcome [6]
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Time to Symptomatic Progression
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Assessment method [6]
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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.
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Timepoint [6]
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From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months)
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Secondary outcome [7]
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Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
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Assessment method [7]
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PK: Mean steady state exposure of abemaciclib.
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Timepoint [7]
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Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
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Secondary outcome [8]
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PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
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Assessment method [8]
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PK: Mean steady state exposure of abemaciclib metabolite LSN2839567.
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Timepoint [8]
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C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
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Secondary outcome [9]
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PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
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Assessment method [9]
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PK: Mean steady state exposure of abemaciclib metabolite LSN3106726.
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Timepoint [9]
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C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
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Secondary outcome [10]
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PK: Mean Steady State Exposure of Abiraterone Acetate
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Assessment method [10]
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PK: Mean Steady State Exposure of Abiraterone Acetate.
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Timepoint [10]
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C1 D15, Post dose
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Secondary outcome [11]
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Time to Worst Pain Progression
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Assessment method [11]
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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).
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Timepoint [11]
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From Randomization Through Follow-up (Up to 60 months)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
393
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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Southside Cancer Care Centre - Kogarah
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Recruitment hospital [3]
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Macquarie University - Macquarie University
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Recruitment hospital [4]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [6]
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St Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2228 - Kogarah
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Recruitment postcode(s) [3]
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2109 - Macquarie University
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment postcode(s) [6]
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3065 - Melbourne
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Recruitment outside Australia
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Arizona
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Arkansas
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Colorado
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Florida
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Indiana
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Nevada
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New York
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Tennessee
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Vermont
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Anhui
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China
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Gansu
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Guangdong
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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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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Shandong
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China
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Tianjin
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Xinjiang
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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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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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Shizuoka
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Tokyo
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Gifu
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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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Zuid-Holland
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Utrecht
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Romania
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Constan?a
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Romania
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Dolj
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Romania
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Bucure?ti
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Spain
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Barcelona [Barcelona]
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Spain
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Catalunya [Cataluña]
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Spain
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Madrid, Comunidad De
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Spain
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Málaga
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Spain
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03706365
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
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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)
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Address
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Eli Lilly and Company
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/65/NCT03706365/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/65/NCT03706365/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03706365
Download to PDF