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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03748641




Registration number
NCT03748641
Ethics application status
Date submitted
19/11/2018
Date registered
21/11/2018
Date last updated
18/09/2020

Titles & IDs
Public title
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
Scientific title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer
Secondary ID [1] 0 0
2017-003364-12
Secondary ID [2] 0 0
CR108534
Universal Trial Number (UTN)
Trial acronym
MAGNITUDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Castration-Resistant Prostatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Niraparib
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo
Treatment: Drugs - Niraparib and Abiraterone acetate FDC

Experimental: Cohort 1: Participants with mCRPC and HRR gene alteration - Participants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg.

Experimental: Cohort 2: Participants with mCRPC and No HRR Gene alteration - Participants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg.

Experimental: Cohort 3 (Open-label): Participants with mCRPC - Participants with mCRPC will receive a fixed dose combination (FDC) of niraparib 200 mg and AA 1000 mg tablets as well as prednisone 10 mg.


Treatment: Drugs: Niraparib
Participants will receive niraparib 200 mg capsules once daily.

Treatment: Drugs: Abiraterone Acetate
Participants will receive AA 1000 mg tablets once daily.

Treatment: Drugs: Prednisone
Participants will receive prednisone 10 mg tablets daily.

Treatment: Drugs: Placebo
Participants will receive matching placebo once daily.

Treatment: Drugs: Niraparib and Abiraterone acetate FDC
Participants will receive niraparib 200 mg and AA 1000 mg as combination tablets once daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1 and 3: Radiographic Progression Free Survival (rPFS) - As per blinded independent central review, rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) as follows: progression of soft tissue lesions measured by computed tomography/magnetic resonance imaging as per response evaluation criteria in solid tumors (RECIST) 1.1; progression by bone lesions observed by bone scan and based on PCWG3. As per criteria, any bone progression must be confirmed by a subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan will be baseline to which all subsequent scans will be compared to determine progression. Participants whose confirmatory scan shows >=2 new lesions will be considered to have bone scan progression and participants whose confirmatory scans did not show >= 2 new lesions will not be considered to have bone scan progression when compared to Week 8 scan.
Timepoint [1] 0 0
Up to 28 months
Secondary outcome [1] 0 0
Cohort 1: Overall survival (OS) - OS is defined as the time from date of randomization to date of death from any cause.
Timepoint [1] 0 0
Up to 66 months
Secondary outcome [2] 0 0
Cohort 1: Time to Symptomatic Progression - Time to symptomatic progression is defined as the need to initiate/record any of the following; a. the use of external beam radiation therapy (EBRT) for skeletal symptoms; b. the need for tumor-related orthopedic surgical intervention; c. other cancer-related procedures (for example: nephrostomy insertion, bladder catheter insertion, EBRT, or surgery for tumor symptoms other than skeletal); d. cancer-related morbid events (for example: fracture [symptomatic and/or pathologic, cord compression, urinary obstructive events); e. initiation of new systemic anti-cancer therapy because of cancer pain.
Timepoint [2] 0 0
Up to 28 months
Secondary outcome [3] 0 0
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy - Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
Timepoint [3] 0 0
Up to 28 months
Secondary outcome [4] 0 0
Cohort 1: Observed Plasma Concentrations of Niraparib - Observed plasma concentrations of niraparib with descriptive statistics will be reported.
Timepoint [4] 0 0
Cycle 2 to 7; Each Cycle is of 28 days (Up to 7 months)
Secondary outcome [5] 0 0
Cohort 1: Observed Trough Plasma Concentrations of Abiraterone - Observed trough plasma concentrations of abiraterone with descriptive statistics will be reported.
Timepoint [5] 0 0
Cycles 2 and 3; Each Cycle is of 28 days (Up to 3 months)
Secondary outcome [6] 0 0
Cohort 1: Number of Participants with Treatment-Emergent Adverse events (TEAEs) - An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention. AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. TEAEs are those events that occur or worsen on or after first dose of study drug through 30 days after last dose of study drug.
Timepoint [6] 0 0
Up to 66 months
Secondary outcome [7] 0 0
Cohort 1: Number of Participants with Treatment-Emergent Adverse events by Severity - Adverse event is any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. TEAEs are those events that occur or worsen on or after first dose of study drug through 30 days after last dose of study drug. Severity criteria includes grades: 1) Mild: easily tolerated, causing minimal discomfort and no interference with everyday activities; 2) Moderate: sufficient discomfort to cause interference with normal activity; 3) Severe: extreme distress, significant impairment of functioning/incapacitation. Prevents everyday activities; 4) Life-threatening: urgent intervention indicated and 5) Death.
Timepoint [7] 0 0
Up to 66 months
Secondary outcome [8] 0 0
Cohort 1: Number of Participants with Laboratory Abnormalities as Measure of Safety - Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined.
Timepoint [8] 0 0
Up to 66 months

Eligibility
Key inclusion criteria
- HRR gene alteration (as identified by the sponsor's required assays) as follows:

1. Cohort 1: positive for HRR gene alteration

2. Cohort 2: not positive for DRD (that is, HRR gene alteration)

- Metastatic disease documented by positive bone scan or metastatic lesions on computed
tomography (CT) or magnetic resonance imaging (MRI)

- Metastatic prostate cancer in the setting of castrate levels of testosterone less than
or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone
analog (GnRHa) or bilateral orchiectomy

- Able to continue GnRHa during the study if not surgically castrate

- Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst
pain in last 24 hours)
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP)
inhibitor

- Systemic therapy (that is, novel second-generation AR-targeted therapy such as
enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4
months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the
metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the
mCRPC setting

- Symptomatic brain metastases

- History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia
(AML)

- Other prior malignancy (exceptions: adequately treated basal cell or squamous cell
skin cancer, superficial bladder cancer, or any other cancer in situ currently in
complete remission) <= 2 years prior to randomization, or malignancy that currently
requires active systemic therapy

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 administering the treatment/s
The people assessing the outcomes
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
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)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [6] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Macquarie University - Macquarie University
Recruitment hospital [9] 0 0
Cabrini Health - Malvern
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - Melbourne
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Fiona Stanley Hospital - Murdoch
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Hollywood Private Hospital - Nedlands
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Prince Of Wales Hospital - Randwick
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Sydney Adventist Hospital - Wahroonga
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Wollongong Private Hospital - Wollongong
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5116 - Adelaide
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4217 - Benowa
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4575 - Birtinya
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4102 - Brisbane
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2050 - Camperdown
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2010 - Darlinghurst
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7000 - Hobart
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2109 - Macquarie University
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3144 - Malvern
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3000 - Melbourne
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6150 - Murdoch
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6009 - Nedlands
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2031 - Randwick
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2076 - Wahroonga
Recruitment postcode(s) [15] 0 0
2500 - Wollongong
Recruitment outside Australia
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effectiveness of niraparib in combination with
abiraterone acetate plus prednisone (AAP) compared to AAP plus placebo.
Trial website
https://clinicaltrials.gov/show/NCT03748641
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03748641