Clinical Trials /

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

NCT04577833

Description:

The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
  • Official Title: An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: CR108783
  • SECONDARY ID: 2019-000137-39
  • SECONDARY ID: 67652000PCR1001
  • NCT ID: NCT04577833

Conditions

  • Prostatic Neoplasms

Interventions

DrugSynonymsArms
NiraparibTreatment Sequence ABD
Abiraterone Acetate (AA)Treatment Sequence ABD
PrednisoneTreatment Sequence ABD

Purpose

The purpose of this study is to determine the bioequivalence (BE) and relative bioavailability (rBA) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

Trial Arms

NameTypeDescriptionInterventions
Treatment Sequence ABDExperimentalParticipants will receive single doses of niraparib and abiraterone acetate (AA) using niraparib Formulation 1 as Treatment A in Treatment Period 1, followed by multiple doses of niraparib and AA using niraparib Formulation 2 as Treatment B in Treatment Period 2, followed by multiple doses of niraparib and AA using niraparib Formulation 4 as Treatment D in Treatment Period 3. From Period 2 onwards and during Extension Phase, all participants will continue to receive treatment with niraparib and AA plus prednisone.
  • Niraparib
  • Abiraterone Acetate (AA)
  • Prednisone
Treatment Sequence ADBExperimentalParticipants will receive Treatment A in Treatment Period 1 followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension Phase all participants will continue to receive treatment with niraparib plus AA along with prednisone.
  • Niraparib
  • Abiraterone Acetate (AA)
  • Prednisone
Treatment Sequence CBDExperimentalParticipants will receive single doses of niraparib and AA using niraparib Formulation 3 as Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3. From Period 2 onwards and during Extension Phase all participants will continue to receive treatment with niraparib plus AA along with prednisone.
  • Niraparib
  • Abiraterone Acetate (AA)
  • Prednisone
Treatment Sequence CDBExperimentalParticipants will receive Treatment C in Treatment Period 1, followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension Phase all participants will continue to receive treatment with niraparib plus AA along with prednisone.
  • Niraparib
  • Abiraterone Acetate (AA)
  • Prednisone

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate

          -  Diagnosed with metastatic castration-resistant prostate cancer (mCRPC), who in the
             opinion of the investigator may benefit from treatment in this study

          -  Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy during the
             study if not surgically castrate (that is, participants who have not undergone
             bilateral orchiectomy)

          -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal
             to (<=) 1

          -  Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade <= 1
             (except alopecia, local skin fibrosis/reaction or Grade <= 2 neuropathy) at screening

        Exclusion Criteria:

          -  Symptomatic brain metastases

          -  Prior disease progression during treatment with abiraterone acetate (AA) and a poly
             adenosine diphosphate (ADP)-ribose polymerase inhibitor (PARPi). Prior discontinuation
             of treatment with AA or PARPi due to AA- or PARPi related toxicity.

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

          -  Known allergies, hypersensitivity, or intolerance to niraparib or abiraterone acetate
             (AA) or the corresponding excipients of niraparib/AA

          -  Evidence of serious active viral, bacterial or uncontrolled systemic fungal infection

          -  Active hepatitis B virus (example, hepatitis B surface antigen [HBsAg] reactive) or
             active hepatitis C virus (HCV) (example, HCV ribonucleic acid [RNA] [qualitative] is
             detected)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3]
Time Frame:Predose, up to 10 hour post dose
Safety Issue:
Description:Cmax,ss is defined as maximum observed analyte concentration at steady state.

Secondary Outcome Measures

Measure:Maximum Observed Analyte Concentration at (Cmax) of Niraparib and AA (Period 1)
Time Frame:Predose, up to 72 hours post dose
Safety Issue:
Description:Cmax is defined as maximum observed analyte concentration.
Measure:Area Under the Plasma Concentration-time Curve from Time Zero to 168 Hours (AUC [0-168h]) of Niraparib and AA (Period 1)
Time Frame:Predose, up to 168 hours post dose
Safety Issue:
Description:AUC (0-168h) is defined as area under the plasma concentration-time curve from time zero to 168 hours post dosing.
Measure:Ratio of individual AUC (0-168h) Values Between Test and Reference Treatment (Period 1)
Time Frame:Predose, up to 168 hours post dose
Safety Issue:
Description:Ratio of individual AUC (0-168h) values between test and reference treatment will be assessed.
Measure:Serum Testosterone Level
Time Frame:Predose on Day -7, Day 15 and Day 29
Safety Issue:
Description:Serum testosterone level will be assessed.
Measure:Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame:From study start until study completion (up to 3.8 years)
Safety Issue:
Description:An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measure:Number of Participants with AEs by Severity
Time Frame:From study start until study completion (up to 3.8 years)
Safety Issue:
Description:Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
Measure:Number of Participants with Clinical Laboratory Abnormalities
Time Frame:From study start until study completion (up to 3.8 years)
Safety Issue:
Description:Number of participants with clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

October 5, 2020