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Niraparib + Abiraterone for Prostate Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT03207347Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment Sequence ABD
- Group 2: Treatment Sequence ADB
- Group 3: Treatment Sequence CBD
- Group 4: Treatment Sequence CDB
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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"
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."
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."
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."
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."
In what medical contexts is Niraparib typically utilized?
"Potential ailments that can be managed using Niraparib include thyroiditis, ulcerative colitis, and various malignancies."
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