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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

No Placebo-Only Group

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

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

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met