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Hormone Therapy
Niraparib + Abiraterone for Prostate Cancer
Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study start until study completion (up to 3.1 years)
Awards & highlights
Study Summary
This trial is testing different strengths and formulations of niraparib and abiraterone acetate to see how well they are absorbed by the body.
Who is the study for?
Men with metastatic castration-resistant prostate cancer (mCRPC) who may benefit from the study treatments. Participants should be able to continue hormone therapy if not surgically castrated, have a performance status indicating they are relatively active and can care for themselves, and must provide a tumor sample for genetic testing.Check my eligibility
What is being tested?
The trial is examining different strengths and formulations of Niraparib and Abiraterone Acetate (AA) under modified fasted conditions to see how well the body absorbs them in men with mCRPC. The study has multiple periods to assess relative bioavailability and bioequivalence.See study design
What are the potential side effects?
Potential side effects include fatigue, nausea, vomiting, anemia, low blood counts leading to increased infection risk or bleeding problems, liver function changes, joint pain or swelling, high blood pressure, hot flushes or skin rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can continue hormone therapy during the study if I haven't had surgery to remove my testicles.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
My prostate cancer was confirmed by a lab test.
Select...
I am willing to give a sample of my tumor for genetic testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study start until study completion (up to 3.1 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study start until study completion (up to 3.1 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours at Steady State (AUC [0-24h],ss) of Niraparib and AA (Period 2 and Period 3)
Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3]
Ratio of Individual Cmax,ss Values Between Test and Reference Treatment (Period 2 and Period 3)
+1 moreSecondary outcome measures
Area Under the Plasma Concentration-time Curve from Time Zero to 72 Hours (AUC [0-72h]) of Niraparib and AA (Period 1)
Maximum Observed Analyte Concentration at (Cmax) of Niraparib and AA (Period 1)
Number of Participants with AEs by Severity
+4 moreSide effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Urinary tract infection
9%
Dehydration
9%
Back pain
9%
Blood bilirubin increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Hypotension
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Depression
4%
Hyponatremia
4%
Hypokalemia
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Trial Design
4Treatment groups
Experimental Treatment
Group I: Treatment Sequence CDBExperimental Treatment3 Interventions
Participants 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 and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.
Group II: Treatment Sequence CBDExperimental Treatment3 Interventions
Participants 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 and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.
Group III: Treatment Sequence ADBExperimental Treatment3 Interventions
Participants 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 and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.
Group IV: Treatment Sequence ABDExperimental Treatment3 Interventions
Participants 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 and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AA-prednisone (AAP) or AAP alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,172 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,769 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can continue hormone therapy during the study if I haven't had surgery to remove my testicles.I have advanced prostate cancer that is not responding to hormone therapy.I am fully active or have some restrictions but can still care for myself.My prostate cancer was confirmed by a lab test.I am willing to give a sample of my tumor for genetic testing.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Sequence ABD
- Group 2: Treatment Sequence ADB
- Group 3: Treatment Sequence CBD
- Group 4: Treatment Sequence CDB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives is the research team hoping to achieve from this investigation?
"As stated by the trial sponsor, Janssen Research & Development, LLC, the primary outcome of this study will be Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone acetate over a Pre-dose to 24 hours post dose period. Additionally, secondary outcomes such as Area Under the Plasma Concentration-time Curve from Time Zero to 72 Hours (AUC [0-72h]) of Niraparib and AA in Period 1; Number of Participants with Adverse Events by Severity graded using National Cancer Institute Common Terminology Criteria"
Answered by AI
Are there other investigations that have been conducted with Niraparib?
"Currently, 457 studies are investigating the efficacy of Niraparib with 110 in Phase 3. Though many trials for this drug take place in Duarte, California, there is an extensive network of 19255 clinical trial sites worldwide conducting research on its potential benefits."
Answered by AI
To what extent is this study populated with volunteers?
"Unfortunately, this clinical trial has ceased recruiting new participants. The posting was initially published on November 13th 2020 and recently modified on the 22nd of Novemeber 2022. However, those exploring other studies may find 1252 trials actively enrolling patients with prostate cancer and 457 research projects currently accepting candidates for Niraparib treatment."
Answered by AI
Does this research endeavor currently have openings for participants?
"This clinical trial has closed its recruitment window. It was initially posted on November 13th 2020 and concluded accepting applications on November 22nd 2022. Alternatively, there are presently 1252 medical studies enrolling patients with prostate cancer and 457 trials recruiting for Niraparib treatment."
Answered by AI
What potential hazards could arise from the utilization of Niraparib?
"As this is a Phase 1 trial, and therefore has limited data regarding efficacy and safety, our team at Power estimated the safety of Niraparib to be rated a 1."
Answered by AI
In what medical contexts is Niraparib typically utilized?
"Potential ailments that can be managed using Niraparib include thyroiditis, ulcerative colitis, and various malignancies."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
California
British Columbia
How old are they?
18 - 65
What site did they apply to?
START Mountain Region
Hosp. Univ. Fund. Jimenez Diaz
What portion of applicants met pre-screening criteria?
Met criteria
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