Niraparib for Metastatic Pancreatic Cancer

(NIRA-PANC Trial)

Recruiting at 5 trial locations

Overseen By Clinical Trials Nurse Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas Medical Center

Must not be taking: Poly polymerase inhibitors

Disqualifiers: Pregnancy, Breastfeeding, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn if Niraparib can help to control metastatic pancreatic cancer. The safety of this drug will also be studied. Niraparib is FDA approved and commercially available for the treatment of ovarian cancer. Its use in this study is investigational.

Research Team

Anup Kasi, MD

Principal Investigator

The University of Kansas Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I, or my legal representative, understand this study and agree to sign the consent form.

My cancer has a mutation in the DNA repair genes.

My cancer can be measured by tests.

Exclusion Criteria

Current or anticipated use of other investigational agents while participating in this study

I have never been diagnosed with MDS or AML.

Patients have had investigational therapy administered within the past 4 weeks

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Niraparib 300 mg daily for 28 days per cycle, with dose adjustments based on weight and platelet count

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Niraparib

Trial Overview 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.

Participant Groups

Group I: Niraparib Treatment Experimental Treatment 1 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)).

Niraparib is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Zejula for:

• Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
• Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

Approved in United States as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
• Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

Approved in Canada as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Tesaro, Inc.

Industry Sponsor

Trials

57

Recruited

10,600+