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Niraparib

Pancrelipase

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Poly(ADP-ribose) Polymerase Inhibitors

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* 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 Treatment

Anup Kasi, MD

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.

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

Defined as the percentage of participants with overall response to therapy at 8 weeks, defined as Partial Response or Complete Response (PR + CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Calculated as the percentage of participants with PFS from the time of initial study treatment until the time of progression, defined per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Calculated as the average length of time of survival from the time of initial study treatment until the time of death from any cause.

Calculated as the percentage of participants that achieve any of the following at 8 weeks: complete response, partial response, or stable disease, as defined by RECIST v1.1

Calculated as the average length of time between response to treatment and disease progression, defined per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Defined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial	NCT03553004	Pancreatic Canc...	Niraparib Treat...	18 Years -	University of Kansas Medical Center
Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial	NCT03553004	Pancreatic Canc...	Niraparib Treat...	18 Years -	University of Kansas Medical Center

Spots Global Cancer Trial Database for niraparib treatment