Therapy Detail

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Therapy Name Niraparib
Synonyms
Therapy Description

Zejula (niraparib) binds to and inhibits PARP, which may result in the accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved for use as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy, and as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring deleterious or suspected deleterious germline BRCA mutations and in complete or partial response to platinum-based chemotherapy (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Niraparib Zejula MK4827 PARP Inhibitor (Pan) 27 Zejula (niraparib) binds to and inhibits PARP, which may result in the accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved for use as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy, and as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring deleterious or suspected deleterious germline BRCA mutations and in complete or partial response to platinum-based chemotherapy (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ARID1A A35Gfs*76 cholangiocarcinoma no benefit Niraparib Preclinical - Patient cell culture Actionable In a preclinical study, a cholangiocarcinoma patient-derived xenograft (PDX) cell line harboring ARID1A A35Gfs*76 was insensitive to Zejula (niraparib) in culture (PMID: 36374558). 36374558
PTEN negative prostate cancer not predictive Niraparib Phase I Actionable In a Phase I trial, negative PTEN IHC staining was not associated with response to Zejula (niraparib) treatment in patients with castration-resistant prostate cancer (PMID: 23810788; NCT00749502). 23810788
IDH1 R132H Advanced Solid Tumor sensitive Niraparib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing IDH1 R132H demonstrated increased sensitivity to Zejula (niraparib)-induced growth inhibition in culture (PMID: 28148839). 28148839
IDH1 R132C cholangiocarcinoma no benefit Niraparib Preclinical - Patient cell culture Actionable In a preclinical study, cholangiocarcinoma patient-derived xenograft (PDX) cell lines harboring IDH1 R132C were insensitive to Zejula (niraparib) in culture (PMID: 36374558). 36374558

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01905592 Phase III Niraparib A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients (BRAVO) Terminated USA | ITA | FRA | ESP | CAN | BEL 8
NCT04592237 Phase II Niraparib Cabazitaxel + Carboplatin + Cetrelimab Cetrelimab + Niraparib Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer Recruiting USA 0
NCT04992013 Phase II Niraparib Niraparib in Tumors Metastatic to the CNS Recruiting USA 0
NCT03891576 Phase II Niraparib Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer) (Newton) Recruiting ITA | DEU 0
NCT04240106 Phase II Niraparib Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN) Terminated ESP 0
NCT05076513 Phase I Niraparib Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma Recruiting USA 0
NCT03945721 Phase I Niraparib A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients Recruiting USA 0
NCT03329001 Phase I Niraparib Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Compared to Niraparib Capsule Active, not recruiting USA 0
NCT05174455 Phase II Niraparib Niraparib for the Treatment of Leiomyosarcoma Not yet recruiting USA 0
NCT05442749 Phase II Niraparib Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer (PARPi-PANC) Recruiting FRA 0
NCT03016338 Phase II Niraparib Study of Niraparib in Recurrent Endometrial Cancer Active, not recruiting CAN 0
NCT04641247 Phase II Niraparib A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study Active, not recruiting USA | ITA | FRA | ESP | CAN | AUT 2
NCT03553004 Phase II Niraparib Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial Recruiting USA 0
NCT03308942 Phase II Niraparib Niraparib + Pembrolizumab Dostarlimab-gxly + Niraparib Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Completed USA 0
NCT02655016 Phase III Niraparib A Study of Niraparib Maintenance Treatment in Patients With HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 13
NCT03602859 Phase III Dostarlimab-gxly + Niraparib Niraparib A Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer (FIRST) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 12
NCT01847274 Phase III Niraparib A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer Completed USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 7
NCT02854436 Phase II Niraparib An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies Active, not recruiting USA | FRA | ESP | CAN | BEL 10
NCT03088059 Phase II Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil Biomarker-based Study in R/M SCCHN (UPSTREAM) Recruiting ITA | FRA | BEL 1
NCT04655183 Phase Ib/II Niraparib + VX-803 Niraparib Study of M4344 in Combination With Niraparib Withdrawn 0
NCT02500901 Phase I Niraparib Enzalutamide Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) Terminated USA 0
NCT04861181 FDA approved Niraparib NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients. (NIRAPK) Recruiting FRA 0
NCT03598270 Phase III Carboplatin + Gemcitabine Niraparib Carboplatin + Pegylated liposomal doxorubicin Atezolizumab + Carboplatin + Pegylated liposomal doxorubicin Atezolizumab + Carboplatin + Gemcitabine Atezolizumab + Carboplatin + Paclitaxel Carboplatin + Paclitaxel Atezolizumab + Niraparib Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer (ANITA) Active, not recruiting ITA | FRA | ESP | DEU | BEL 0
NCT04030559 Phase II Niraparib Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects Recruiting USA 0
NCT05406700 Phase I Niraparib Niraparib In Recurrent IDH 1/2 Gliomas Recruiting USA 0
NCT03644342 Phase Ib/II Niraparib Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix (NIVIX) Suspended USA 0
NCT03359850 Phase I Niraparib Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients Completed USA 0
NCT05615818 Phase III Niraparib ZW25 Binimetinib + Encorafenib Futibatinib Cisplatin + Gemcitabine Neratinib + Trastuzumab Ivosidenib Personalized Medicine for Advanced Biliary Cancer Patients (SAFIR-ABC10) Not yet recruiting FRA | BEL 1
NCT05672095 Phase Ib/II Niraparib Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer Not yet recruiting USA 0
NCT03601923 Phase II Niraparib Niraparib in Patients With Pancreatic Cancer Recruiting USA 0
NCT04080284 Phase II Niraparib Trial of Maintenance With Niraparib- Uterine Serous Carcinoma Recruiting USA 0
NCT03651206 Phase II Paclitaxel + Pegylated liposomal doxorubicin + Topotecan Doxorubicin + Gemcitabine + Paclitaxel Niraparib Dostarlimab-gxly + Niraparib Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib (ROCSAN) Recruiting FRA 0
NCT04037254 Phase II Niraparib Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer Recruiting USA 0
NCT04288687 Phase II Niraparib A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects Recruiting USA 0
NCT04221503 Phase II Niraparib Niraparib/TTFields in GBM Active, not recruiting USA 0
NCT05169437 Phase II Niraparib Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors Recruiting USA 0
NCT03840967 Phase II Niraparib A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma Recruiting USA 0
NCT05455424 Phase II Niraparib Niraparib Efficacy in Patient With Unresectable Mesothelioma (NERO) Recruiting 1
NCT04584255 Phase II Dostarlimab-gxly + Niraparib Niraparib Niraparib + Dostarlimab In BRCA Mutated Breast Cancer Recruiting USA 0
NCT03329937 Phase I Niraparib Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment Completed USA 0
NCT03925350 Phase II Niraparib Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation Recruiting USA 0
NCT02354131 Phase Ib/II Niraparib Bevacizumab + Niraparib Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer (AVANOVA) Completed USA 1
NCT05238831 Phase II Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole SMMART Adaptive Clinical Treatment (ACT) Trial Not yet recruiting USA 0
NCT03207347 Phase II Niraparib A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) Completed USA 0
NCT05515575 Phase II Niraparib A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA Recruiting USA 0
NCT05297864 Phase II Niraparib PARP Inhibition for Gliomas (PI-4G or pi4g) Recruiting USA 0
NCT02354586 Phase II Niraparib A Study of Niraparib in Patients With Ovarian Cancer Who Have Received at Least Three Previous Chemotherapy Regimens Completed USA | CAN 0
NCT04915755 Phase III Niraparib Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Either Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease (ZEST) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 18


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