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A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE)

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ClinicalTrials.gov Identifier: NCT04497844
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE July 31, 2020
First Posted Date  ICMJE August 4, 2020
Last Update Posted Date August 20, 2021
Actual Study Start Date  ICMJE September 23, 2020
Estimated Primary Completion Date November 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
Radiographic Progression-free Survival (rPFS) [ Time Frame: Up to 47 months ]
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) criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
  • Overall Survival (OS) [ Time Frame: Up to 78 months ]
    OS is defined as the time from date of randomization to date of death from any cause.
  • Symptomatic Progression-free Survival [ Time Frame: Up to 47 months ]
    Symptomatic progression free survival is defined as time from the date of randomization to the onset of symptoms consistent with progression of metastatic prostate cancer.
  • Time to Subsequent Therapy [ Time Frame: Up to 47 months ]
    Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 78 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Official Title  ICMJE A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Brief Summary The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Detailed Description Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AA-P) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib is an investigational agent in the castration-sensitive cancer population and has been approved for the treatment of ovarian cancer. The addition of niraparib to the AA-P backbone regimen may improve initial disease control and long-term outcomes compared with AA-P alone in a biomarker selected population. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumor measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castrate Sensitive Prostate Cancer
Intervention  ICMJE
  • Drug: Niraparib
    Participants will receive Niraparib 200 mg once daily.
  • Drug: Abiraterone acetate (AA)
    Participants will receive AA 1000 mg once daily.
  • Drug: Prednisone
    Participants will receive prednisone 5 mg once daily.
  • Drug: Placebo for Niraparib
    Participants will receive matching placebo for Niraparib once daily.
Study Arms  ICMJE
  • Experimental: Niraparib with Abiraterone Acetate plus Prednisone (AA-P)
    Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
    Interventions:
    • Drug: Niraparib
    • Drug: Abiraterone acetate (AA)
    • Drug: Prednisone
  • Experimental: AA plus Prednisone (AA-P)
    Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.
    Interventions:
    • Drug: Prednisone
    • Drug: Placebo for Niraparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2020)
788
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 7, 2027
Estimated Primary Completion Date November 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Diagnosis of prostate adenocarcinoma
  • Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
  • Metastatic disease as documented by at least one bone lesion
  • Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and willing to continue through the treatment phase.
  • Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC): (a) maximum of 1 course of radiation or surgical intervention to manage symptoms of prostate cancer. Radiation with curative intent is not allowed. Radiation must be completed prior to randomization (b) <= 6 months of androgen deprivation therapy (ADT) prior to randomization; and (c) 30 days of abiraterone acetate + prednisone (AA-P) allowed if required

Exclusion criteria:

  • Prior treatment with a poly (adenosine diphosphate-ribose) polymerase (inhibitor) (PARP) inhibitor- History of adrenal dysfunction
  • Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
  • History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belarus,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czechia,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Moldova, Republic of
 
Administrative Information
NCT Number  ICMJE NCT04497844
Other Study ID Numbers  ICMJE CR108852
2020-002209-25 ( EudraCT Number )
67652000PCR3002 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP