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Niraparib + Carboplatin for Solid Cancers
Study Summary
This trial is designed to find a recommended dose and schedule of niraparib plus carboplatin for patients with evidence of HRD, as well as to establish the anti-tumor efficacy of the treatment.
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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- You are 18 years old or older.You are able to perform your daily activities without assistance or with only slight assistance.You have already tried and not responded well to the usual first line treatments that help people. If you have refused standard treatment, you can still participate, but it needs to be recorded.If you have a gene mutation that is known to cause problems with DNA repair, and it has been confirmed by testing and medical literature, you may not be eligible. Variations that are not well understood will also not be eligible.You have a specific genetic mutation that affects your body's ability to repair damaged DNA.You have taken an experimental treatment within the last 4 weeks or within 5 times the amount of time it takes for the treatment to leave your body.You had a different type of cancer (except for skin basal or squamous cell carcinoma) within the past 2 years before starting the trial.Your tumors or lymph nodes are big enough to be measured by CT or MRI scans.You have a type of cancer that can be examined with a biopsy, and you must agree to have four biopsies during the study.Before joining the study, you will be tested for a specific gene mutation called the homologous recombination mutation. If you have this mutation and have had a previous test more than 3 months ago or received treatment, you will need to have another test to confirm the mutation before enrolling in the study.If you have a specific genetic mutation that has already been identified, you do not need to have the testing done again, even if it was done some time ago.You have a digestive system disorder that affects how your body absorbs medication.You have a mental health condition or difficult living circumstances that may make it hard for you to follow the study requirements.You are expected to live for at least three more months.You are expected to live for at least 3 more months.You are able to swallow pills without crushing or breaking them.
- Group 1: Niraparib and Carboplatin
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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 past experiments have been conducted to measure the effects of Niraparib?
"Bristol Royal Hospital for Children conducted the initial research into niraparib in 2002, and since then 851 studies have been finalized. At present, 792 experiments are being actively pursued with many of them based out of Charlotte, North carolina."
Are new participants still being invited to participate in this investigation?
"Affirmative. As evidenced on clinicaltrials.gov, this research initiative is recruiting patients right now and has been since the 13th of October in 2017. 146 individuals need to be enrolled at 4 different medical locations with the most recent update being posted on September 27 2022."
How many participants are currently involved in this clinical investigation?
"Affirmative. According to the information uploaded on clinicaltrials.gov, this medical trial is still seeking patients after being initial posted on October 13th 2017 and last updated September 27th 2022. An estimated 146 individuals will be recruited from 4 different sites."
Has the FDA granted approval for Niraparib to be used therapeutically?
"Due to the lack of evidence on Niraparib's safety and efficacy, we at Power rated it a 1 on our scale."
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