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| Name | Class |
|---|---|
| Tesaro, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib Treatment | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib Treatment | Drug | Niraparib treatment by mouth (oral) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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). | Up to 5 years |
| Overall Survival (OS) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup Kasi, MD | The University of Kansas Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Cancer Center - Clinical Research Center | Fairway | Kansas | 66208 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42249558 | Derived | Kasi A, Al-Rajabi RMT, Baranda JC, Saeed A, Dai J, Chalise P, Weir S, Sear B, Carroll E, Bradbury S, Tripathi A, Hyter S, Beeki V, McKittrick RJ, Kumer S, Schmitt T, Soper S, Godwin AK, Sun W. Niraparib in pancreatic cancer with germline or somatic DNA damage repair (DDR) gene alterations (BRCA and beyond): A phase II study (NIRA-PANC). Oncologist. 2026 Jun 5:oyag225. doi: 10.1093/oncolo/oyag225. Online ahead of print. | |
| 37759489 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Calculated as the average length of time of survival from the time of initial study treatment until the time of death from any cause. |
| Up to 5 years |
| Disease Control | 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 | 8 weeks |
| Duration of Response | 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). | Up to 5 years |
| Proportion of participants with adverse events (AEs) | Defined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Up to 5 years |
| University of Kansas Cancer Center - West |
| Kansas City |
| Kansas |
| 66112 |
| United States |
| University of Kansas Cancer Center - Overland Park | Overland Park | Kansas | 66210 | United States |
| The University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | United States |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| Derived |
| Freed IM, Kasi A, Fateru O, Hu M, Gonzalez P, Weatherington N, Pathak H, Hyter S, Sun W, Al-Rajabi R, Baranda J, Hupert ML, Chalise P, Godwin AK, A Witek M, Soper SA. Circulating Tumor Cell Subpopulations Predict Treatment Outcome in Pancreatic Ductal Adenocarcinoma (PDAC) Patients. Cells. 2023 Sep 13;12(18):2266. doi: 10.3390/cells12182266. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |