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Niraparib for Pancreatic Cancer
Study Summary
This trial is studying how well niraparib works in treating patients with pancreatic cancer.
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 have a stomach or intestine problem that could affect how I absorb medication.My cancer has specific genetic changes in BRCA1, BRCA2, PALB2, CHEK2, or ATM.I am 18 years old or older.I agree to use birth control from the start of the study until 6 months after it ends.I can swallow and keep down pills.I have not recently had chemotherapy, radiotherapy, immunotherapy, or experimental treatments.You have had a bad reaction to drugs similar to niraparib.I have had another type of cancer in the last 2 years.I have never been diagnosed with MDS or AML.My pancreatic cancer cannot be cured with standard treatments.I have been on a stable dose of corticosteroids for at least 4 weeks.I agree not to donate blood during and for 3 months after the study.I have taken oral cancer treatment or TKI therapy recently.I haven't had a blood transfusion in the last 4 weeks.I do not have any serious ongoing illnesses that could interfere with the study.I am not on blood thinners, or my doctor can pause them for a biopsy.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I am fully active or can carry out light work.I am not pregnant and agree to avoid pregnancy during the study.My blood tests show my organs and bone marrow are working well.You need to have a specific amount of detectable disease according to certain guidelines.I have brain metastases that have not been treated.I had major surgery less than 3 weeks ago.I have been treated with a PARP inhibitor before.I haven't had significant radiation therapy affecting my bone marrow recently.I have undergone at least one treatment for my cancer before.I don't have any health issues that would affect the study or stop me from completing it.I am willing to have a new biopsy before treatment starts.I haven't taken any colony stimulating factors in the last 4 weeks.I do not have HIV.
- Group 1: Niraparib
- 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 is the total cohort size for this research project?
"Affirmative, clinicaltrials.gov data reveals that this experiment is actively enrolling patients. It was originally opened on August 22nd 2018 and last updated April 11th 2022 - with a goal of 32 participants spread across 3 medical sites."
Is this an unprecedented clinical trial?
"Since 2016, Myriad Genetics Inc. has sponsored research projects on Niraparib with the initial study in that year involving 733 participants. This drug was granted Phase 3 approval and currently there are 99 active investigations into its effects across 485 cities of 49 nations worldwide."
Is the enrolment period for this test still open?
"According to clinicaltrials.gov, this research study is currently accepting participants - it was initially posted on August 22nd 2018 and most recently revised on April 11th 2022."
Could you give me a summary of previous experiments utilizing Niraparib?
"Presently, 99 ongoing studies are exploring the potential of Niraparib with 13 being in Phase 3. While concentrations of research can be found in Washington, DC, 2817 separate sites are conducting experiments involving this drug."
To what extent might Niraparib pose a danger to those taking it?
"Although no clinical data is currently available to support the intervention's efficacy, our team at Power has assessed Niraparib as being of medium safety (2/3) due its Phase 2 trial status."
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