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PARP Inhibitor
Niraparib for Metastatic Pancreatic Cancer (NIRA-PANC Trial)
Phase 2
Waitlist Available
Led By Anup Kasi, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Screening tumor tissue analysis positive with germline or somatic mutation in genes involved in DNA repair
Measurable disease
Must not have
Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial will study if Niraparib can help control metastatic pancreatic cancer and its safety.
Who is the study for?
This trial is for adults with metastatic pancreatic cancer who've had prior chemotherapy. They must have specific gene mutations related to DNA repair, be able to take oral medication, and have adequate organ function. Participants need effective birth control if applicable and can't join if they're pregnant or breastfeeding, have certain blood disorders like MDS/AML, are on other clinical trials or investigational drugs within the last 4 weeks, or have severe psychiatric issues.
What is being tested?
The NIRA-PANC trial is testing Niraparib's effectiveness in controlling metastatic pancreatic cancer and monitoring its safety profile. Although approved for ovarian cancer treatment, Niraparib's use here is experimental. The study involves patients taking this oral drug to see how well it works against their cancer.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of Niraparib based on its use in ovarian cancer may include nausea, fatigue, blood cell count changes leading to anemia or infection risks, heart palpitations, insomnia, headache and potential digestive disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a mutation in the DNA repair genes.
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My cancer can be measured by tests.
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My cancer is a type of pancreatic cancer confirmed by lab tests.
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I can swallow pills.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never been diagnosed with MDS or AML.
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I haven't had a blood transfusion in the last 4 weeks.
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I do not have brain or spinal cord cancer spread.
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I am not pregnant, breastfeeding, nor planning to conceive within 6 months after treatment.
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I haven't had significant radiation therapy affecting my bone marrow recently.
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I have been treated with a PARP inhibitor before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Disease Control
Duration of Response
Overall Survival (OS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Niraparib TreatmentExperimental Treatment1 Intervention
* Niraparib 300 milligrams (mg) by mouth daily for 28 days (1 cycle = 28 days)
* (Dose reduced to 200mg dose for participants whose baseline weight is less than 77 kilograms (kg) \[169.756 pounds (lbs)\] or baseline platelet count is less than 150,000 microliters (µL)).
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,437 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,500 Total Patients Enrolled
Anup Kasi, MDPrincipal InvestigatorThe University of Kansas Cancer Center
2 Previous Clinical Trials
114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I, or my legal representative, understand this study and agree to sign the consent form.I have never been diagnosed with MDS or AML.I am not immuno-compromised, but I have had my spleen removed.I haven't had a blood transfusion in the last 4 weeks.I do not have brain or spinal cord cancer spread.I am not pregnant, breastfeeding, nor planning to conceive within 6 months after treatment.My cancer has a mutation in the DNA repair genes.My cancer can be measured by tests.I have had chemotherapy for metastatic disease or cannot undergo chemotherapy.My organs are functioning well.I haven't had significant radiation therapy affecting my bone marrow recently.My cancer is a type of pancreatic cancer confirmed by lab tests.I don't have any health issues that would affect the study or stop me from fully participating.You are currently participating in another clinical trial for a different treatment.I haven't had major surgery in the last 3 weeks and have recovered from any past surgeries.I had cancer other than pancreatic but am now cancer-free.Women need to have a negative pregnancy test within 3 days before starting the study treatment.I can swallow pills.I have been treated with a PARP inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: Niraparib Treatment
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.
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