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Niraparib for Cancer (PAVO Trial)
PAVO Trial Summary
This trial will help researchers learn more about how effective niraparib is for treating solid tumors with a PALB2 mutation.
PAVO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPAVO Trial Timeline
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 • NCT03207347PAVO Trial Design
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Who is running the clinical trial?
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- I've had chemotherapy, biological, hormonal treatments, or radiation within the last 3 weeks.I have stable brain disease and have been on a steady or decreasing dose of steroids for at least a week.I have a BRCA1 or BRCA2 gene mutation.I have been treated with PARP inhibitors before.I have tried all standard treatments for my cancer or cannot tolerate them.My cancer returned after treatment with platinum-based therapy.I have brain-related complications from cancer.I have a confirmed PALB2 gene mutation.My cancer is advanced or has spread and was confirmed by a lab test.I have another cancer that needs treatment.I have ovarian or prostate cancer.I am 18 years old or older.My blood pressure is high even with medication.My genetic test shows uncertain changes in the PALB2 gene, but no harmful mutations.I can provide a recent or new tumor sample for testing.My cancer got worse 14-18 weeks after starting platinum-based treatment.
- Group 1: Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
- 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 other similar trials exist for this medication?
"Research into niraparib began in 2016 with the first clinical trial. Myriad Genetics, Inc. sponsored this initial study of 733 people that took place in 2016. After successful completion, niraparib received Phase 3 drug approval and sparked 96 active trials in 476 cities across 49 countries."
Could you list any similar Niraparib clinical trials that have already taken place?
"Niraparib was first studied in 2016 by GSK. To date, a total of 17 clinical trials have been completed while 96 different ones are ongoing. There is a significant amount of research being done out of Fairfax, Virginia."
What is the present-day status of Niraparib in terms of federal approval?
"There is some data indicating that Niraparib is safe, but none yet supporting its efficacy. It received a score of 2."
How many people will be participating in this clinical trial at most?
"One hundred and ten patients that satisfy the study's requirements are necessary to carry out the research. The sponsor, GlaxoSmithKline, will be managing the trial from several locations like Inova Schar Institute in Fairfax, Virginia as well as Nebraska Cancer Specialists in Omaha, Nebraska."
Are people with the required qualifications able to participate in this clinical trial right now?
"That is correct. The clinicaltrials.gov website lists this trial as recruiting patients. This study was originally posted on March 15th, 2022 and has been updated September 26th, 2022. They are looking for 110 individuals to fill the 76 different spots at various locations."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
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