A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT03748641
• Date of registration: 19/11/2018
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• 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 MAGNITUDE
• 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
• Date of first enrolment: January 25, 2019
• Target sample size: 765
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03748641
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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)

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Castration-Resistant Prostatic Cancer

Intervention(s)

Drug: Prednisone

Drug: Placebo

Drug: Abiraterone Acetate

Drug: New Formulation of Niraparib and Abiraterone Acetate (AA)

Drug: Niraparib

Primary Outcome(s)

Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) [Time Frame: Up to 32 months]

Secondary Outcome(s)

Cohort 1: Time to Symptomatic Progression [Time Frame: Up to 97 months]

Observed Plasma Concentrations of Niraparib [Time Frame: Up to 97 months]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Up to 96 months]

Cohort 1: Overall Survival (OS) [Time Frame: Up to 97 months]

Number of Participants With Treatment-Emergent Adverse Events by Severity [Time Frame: Up to 96 months]

Cohort 1: Time to Initiation of Cytotoxic Chemotherapy [Time Frame: Up to 97 months]

Number of Participants With Abnormalities in Laboratory Values [Time Frame: Up to 96 months]

Observed Plasma Concentrations of Abiraterone [Time Frame: Up to 97 months]

Secondary ID(s)

CR108534

64091742PCR3001

2017-003364-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/10/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03748641