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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03748641
Ethics application status
Date submitted
19/11/2018
Date registered
21/11/2018
Date last updated
24/10/2024

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 - New Formulation of Niraparib and Abiraterone Acetate (AA)

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. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and 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. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.

Experimental: Cohort 3 (Open-label): Participants with mCRPC - Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.


Treatment: Drugs: Niraparib
Participants will receive niraparib 200 mg capsules or tablets 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: New Formulation of Niraparib and Abiraterone Acetate (AA)
Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to 32 months
Primary outcome [2] 0 0
Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [2] 0 0
Up to 32 months
Secondary outcome [1] 0 0
Cohort 1: Overall Survival (OS)
Timepoint [1] 0 0
Up to 97 months
Secondary outcome [2] 0 0
Cohort 1: Time to Symptomatic Progression
Timepoint [2] 0 0
Up to 97 months
Secondary outcome [3] 0 0
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
Timepoint [3] 0 0
Up to 97 months
Secondary outcome [4] 0 0
Observed Plasma Concentrations of Niraparib
Timepoint [4] 0 0
Up to 97 months
Secondary outcome [5] 0 0
Observed Plasma Concentrations of Abiraterone
Timepoint [5] 0 0
Up to 97 months
Secondary outcome [6] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [6] 0 0
Up to 96 months
Secondary outcome [7] 0 0
Number of Participants With Treatment-Emergent Adverse Events by Severity
Timepoint [7] 0 0
Up to 96 months
Secondary outcome [8] 0 0
Number of Participants With Abnormalities in Laboratory Values
Timepoint [8] 0 0
Up to 96 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)
3. Cohort 3: eligible by HRR status
* 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
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/02/2027
Actual
Sample size
Target
Accrual to date
Final
765
Recruitment in Australia
Recruitment state(s)
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Royal Adelaide Hospital - Adelaide
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Pindara Private Hospital - Benowa
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Sunshine Coast University Hospital - Birtinya
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Princess Alexandra Hospital - Brisbane
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St Vincent s Hospital Sydney - Darlinghurst
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Royal Hobart Hospital - Hobart
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Macquarie University - Macquarie University
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Eye Surgery Associates - Malvern
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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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5000 - Adelaide
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4217 - Benowa
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4575 - Birtinya
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4102 - Brisbane
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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) [14] 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 and placebo.
Trial website
https://clinicaltrials.gov/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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