Clinical Trials Logo
  1. Home
  2. Castration-Resistant Prostate Cancer
  3. NCT03748641
  4. Details
NCT03748641 Clinical Trial

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

Castration-Resistant Prostatic Cancer Clinical Trial

— MAGNITUDE  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03748641
Other study ID # CR108534
Secondary ID 2017-003364-1264
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 25, 2019
Est. completion date February 19, 2027

Study information
Verified date May 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

This study will assess efficacy and safety of niraparib in combination with AAP for the treatment of participants with metastatic castration resistant prostate cancer. Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone and selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), which is found in the testes and adrenals, as well as in prostate tissues and tumors. In participants with metastatic prostate cancer, DNA-repair anomalies are identified in approximately 15 percent (%) to 20% of tumors. The study will consist of 5 phases: a prescreening phase for biomarker evaluation only, a screening phase, a treatment phase, a follow up phase, and an extension phase (either open-label extension [OLE] or long-term extension [LTE]). During the prescreening phase participants will be evaluated for homologous recombination repair (HRR) gene alteration status and then will be assigned to one of the 2 cohorts based on their biomarker status. Treatment will be administered daily and is planned to be continuous until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. Efficacy, pharmacokinetics, biomarkers, participants reported outcomes and safety will be assessed. The total duration of study will be approximately 66 months.

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Niraparib
Participants will receive niraparib 200 mg capsules once daily.
• Abiraterone Acetate
Participants will receive AA 1000 mg tablets once daily.
• Prednisone
Participants will receive prednisone 10 mg tablets daily.
• Placebo
Participants will receive matching placebo once daily.
• 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.
See more »

Sponsors (1)
Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  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, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later. Up to 32 months
Secondary Cohort 1: Overall Survival (OS) Up to 97 months
Secondary Cohort 1: Time to Symptomatic Progression Up to 97 months
Secondary Cohort 1: Time to Initiation of Cytotoxic Chemotherapy Up to 97 months
Secondary Observed Plasma Concentrations of Niraparib Up to 97 months
Secondary Observed Plasma Concentrations of Abiraterone Up to 97 months
Secondary Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to 96 months
Secondary Number of Participants With Treatment-Emergent Adverse Events by Severity Up to 96 months
Secondary Number of Participants With Abnormalities in Laboratory Values Up to 96 months
See also
  Status Clinical Trial Phase
Terminated NCT04116164 - Safety and Targeting of Anti-hk2 Antibody in mCRPC Early Phase 1
Not yet recruiting NCT04126915 - Precise Therapy for mCRPC Patients Through Whole Exome Sequencing(PTtWES)
Recruiting NCT04104607 - the Bispecific PSMAxCD3 Antibody CC-1 in Patients With Castration Resistant Prostate Carcinoma Phase 1
Recruiting NCT03016741 - Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer Phase 4
Completed NCT02398526 - Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases
Active, not recruiting NCT05551117 - A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors Phase 2
Terminated NCT04404140 - A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC). Phase 1
Recruiting NCT02998567 - Combination Study of Guadecitabine/ASTX727 and Pembrolizumab Phase 1
Recruiting NCT05293496 - A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors Phase 1
Available NCT06033001 - Expanded Access Treatment With [Lu-177]-PNT2002 for Adult Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)