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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

NIRA-PANC Trial 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.Check my eligibility

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.See study design

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.

NIRA-PANC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

NIRA-PANC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Disease Control

Duration of Response

Overall Survival (OS)

+2 more

NIRA-PANC Trial 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)).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

461 Previous Clinical Trials

169,139 Total Patients Enrolled

Tesaro, Inc.Industry Sponsor

56 Previous Clinical Trials

10,538 Total Patients Enrolled

Anup Kasi, MDPrincipal InvestigatorThe University of Kansas Cancer Center

2 Previous Clinical Trials

114 Total Patients Enrolled

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03553004 — Phase 2

Pancreatic Cancer Research Study Groups: Niraparib Treatment

Pancreatic Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT03553004 — Phase 2

Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03553004 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there ever been an identical clinical trial conducted before?

"Investigative study of Niraparib Treatment began back in 2016, under the sponsorship of Myriad Genetics Inc. Following a successful first trial which included 733 participants, this drug was approved for Phase 3 clinical trials. Currently, there are 99 active studies pertaining to Niraparib Treatment located in 485 cities and 49 countries worldwide."

Answered by AI

How many individuals have taken part in this experiment?

"Yes, according to the clinicaltrials.gov data, this medical trial is currently recruiting candidates. It was first posted on January 22nd 2019 and its most recent update occurred in May 17th 2022; 18 patients across 6 sites need to be enrolled for it to succeed."

Answered by AI

Are there any vacancies available in this clinical trial for participants?

"This clinical trial is presently searching for participants, as indicated on the information hosted by clinicaltrials.gov. The initial posting of this study was made on January 22nd 2019 and its most recent update occurred on May 17th 2022."

Answered by AI

Is the Niraparib Therapy regimen secure for those engaging in it?

"Considering the Phase 2 status of this treatment, our team at Power has assigned a score of 2 to Niraparib's safety. This implies that there is some evidence suggesting its security but no data supporting its efficacy."

Answered by AI

Are there any North American research centers testing this hypothesis?

"At the moment, this medical trial has 6 locations that are recruiting patients. These include University of Kansas Cancer Center - Overland Park in Overland Park, The University of Kansas Cancer Center in Westwood and University of Kansas Cancer Center - North in Kansas City. Additionally, there are 3 other sites located across the country."

Answered by AI

Has there been any past research regarding the use of Niraparib as a treatment?

"Niraparib Treatment was first tested at GSK Investigational Site in 2016, with 17 trials having been completed since then. At present, there are 99 studies actively recruiting participants; many of them located within Overland Park, Kansas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial

2019. "Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03553004.

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