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) 30 | 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 |
|---|---|---|---|---|---|---|---|
| RAD51C R193W | ovarian carcinoma | resistant | Niraparib | Preclinical - Cell culture | Actionable | In a preclinical study, ovarian carcinoma cells expressing RAD51C R193W demonstrated resistance to Zejula (niraparib) in culture (PMID: 28588062). | 28588062 |
| 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 |
| 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 |
| 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 |
| RAD51C H192_R193delinsGG | ovarian carcinoma | resistant | Niraparib | Preclinical - Cell culture | Actionable | In a preclinical study, ovarian carcinoma cells expressing RAD51C H192_R193delinsGG demonstrated resistance to Zejula (niraparib) in culture (PMID: 28588062). | 28588062 |
| RAD51C R193L | ovarian carcinoma | resistant | Niraparib | Preclinical - Cell culture | Actionable | In a preclinical study, ovarian carcinoma cells expressing RAD51C R193L demonstrated resistance to Zejula (niraparib) in culture (PMID: 28588062). | 28588062 |
| 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 |
|---|---|---|---|---|---|---|
| NCT03945721 | Phase I | Niraparib | A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients (UNITY) | Recruiting | USA | 0 |
| NCT02925234 | Phase II | Palbociclib Ribociclib Lenvatinib Ipilimumab + Nivolumab Trametinib Crizotinib Niraparib Selpercatinib Olaparib Erlotinib Erdafitinib Dabrafenib Dacomitinib Rucaparib Axitinib Panitumumab Pemigatinib Durvalumab Afatinib Entrectinib Tepotinib Alpelisib Atezolizumab + Bevacizumab Alectinib Regorafenib Cobimetinib + Vemurafenib Nilotinib Vismodegib Abemaciclib Sunitinib Nivolumab Cabozantinib Lorlatinib Talazoparib Dabrafenib + Trametinib Pembrolizumab Pertuzumab + Trastuzumab | The Drug Rediscovery Protocol (DRUP Trial) (DRUP) | Recruiting | NLD | 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 |
| NCT04655183 | Phase Ib/II | Niraparib + VX-803 Niraparib | Study of M4344 in Combination With Niraparib | Withdrawn | 0 | |
| NCT03891576 | Phase II | Niraparib | Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer) (Newton) | Active, not recruiting | ITA | DEU | 0 |
| NCT04288687 | Phase II | Niraparib | A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects | Active, not recruiting | USA | 0 |
| NCT04915755 | Phase III | Niraparib | Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease (ZEST) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 17 |
| NCT05406700 | Phase I | Niraparib | Niraparib In Recurrent IDH 1/2 Gliomas | Recruiting | USA | 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 |
| NCT04080284 | Phase II | Niraparib | Trial of Maintenance With Niraparib- Uterine Serous Carcinoma | Recruiting | USA | 0 |
| NCT05990192 | Phase II | Niraparib | SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy (SOPRANO) | Not yet recruiting | GBR | 0 |
| NCT03651206 | Phase II | Paclitaxel + Pegylated liposomal doxorubicin + Topotecan Doxorubicin + Gemcitabine + Paclitaxel Niraparib Dostarlimab-gxly + Niraparib | Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib (ROCSAN) | Active, not recruiting | FRA | 0 |
| NCT05455424 | Phase II | Niraparib | Niraparib Efficacy in Patient With Unresectable Mesothelioma (NERO) | Active, not recruiting | GBR | 0 |
| NCT05961124 | Phase II | Niraparib | Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer | Recruiting | CAN | 0 |
| 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) | Active, not recruiting | ITA | GBR | FRA | ESP | BEL | 0 |
| NCT06201234 | Phase II | Niraparib Elacestrant + Niraparib | Evaluating the Addition of Elacestrant (Oral SERD) to Niraparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer (ELEMENT) | Not yet recruiting | DEU | 0 |
| NCT04221503 | Phase II | Niraparib | Niraparib/TTFields in GBM | Active, not 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 |
| NCT02354131 | Phase Ib/II | Niraparib Bevacizumab + Niraparib | Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer (AVANOVA) | Completed | USA | 1 |
| NCT04037254 | Phase II | Niraparib | Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer | Suspended | USA | CAN | 0 |
| 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 | NLD | ITA | GBR | FRA | ESP | CAN | BEL | 6 |
| NCT03359850 | Phase I | Niraparib | Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients | Completed | USA | 0 |
| NCT06077877 | Phase Ib/II | GSK4524101 + Niraparib GSK4524101 Niraparib | A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors | Recruiting | USA | CAN | 0 |
| NCT04992013 | Phase II | Niraparib | Niraparib in Tumors Metastatic to the CNS | Recruiting | USA | 0 |
| NCT02500901 | Phase I | Niraparib Enzalutamide | Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) | Terminated | USA | 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 |
| NCT03016338 | Phase II | Niraparib | Study of Niraparib in Recurrent Endometrial Cancer | Active, not recruiting | CAN | 0 |
| NCT01847274 | Phase III | Niraparib | A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | 6 |
| NCT03644342 | Phase Ib/II | Niraparib | Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix (NIVIX) | Suspended | USA | 0 |
| NCT04240106 | Phase II | Niraparib | Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN) | Completed | ESP | 0 |
| NCT03925350 | Phase II | Niraparib | Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation | Unknown status | 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 | GBR | FRA | BEL | 0 |
| NCT05169437 | Phase II | Niraparib | Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors (PAVO) | Active, not recruiting | USA | 0 |
| NCT04584255 | Phase II | Dostarlimab-gxly + Niraparib Niraparib | Niraparib + Dostarlimab In BRCA Mutated Breast Cancer | Recruiting | 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 | GBR | FRA | ESP | DEU | CAN | BEL | 12 |
| NCT03601923 | Phase II | Niraparib | Niraparib in Patients With Pancreatic Cancer | Active, not recruiting | USA | 0 |
| NCT05297864 | Phase II | Niraparib | PARP Inhibition for Gliomas (PI-4G or pi4g) | Terminated | USA | 0 |
| 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | 10 |
| 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 | Withdrawn | 0 | |
| NCT03329937 | Phase I | Niraparib | Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment | Completed | 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 |
| NCT05718323 | Phase II | Niraparib | Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC (RAISE) | Recruiting | ITA | FRA | ESP | 1 |
| NCT05174455 | Phase II | Niraparib | Niraparib for the Treatment of Leiomyosarcoma | Withdrawn | 0 | |
| NCT03553004 | Phase II | Niraparib | Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial | Active, not recruiting | USA | 0 |
| NCT02854436 | Phase II | Niraparib | An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies | Completed | USA | NLD | GBR | FRA | ESP | CAN | BEL | AUS | 7 |
| NCT03329001 | Phase I | Niraparib | Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Compared to Niraparib Capsule | Active, not recruiting | USA | 0 |
| NCT05523440 | Phase II | Bevacizumab + Niraparib Niraparib | Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation | Recruiting | USA | 0 |
| NCT05442749 | Phase II | Niraparib | Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer (PARPi-PANC) | Recruiting | FRA | 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 |
| 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 |
| NCT05672095 | Phase Ib/II | Niraparib | Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer | Not yet recruiting | USA | 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 |
| NCT03840967 | Phase II | Niraparib | A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma | Active, not recruiting | USA | 0 |
| NCT05076513 | Phase I | Niraparib | Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma | Recruiting | USA | 0 |
| NCT05515575 | Phase II | Niraparib | A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA | Active, not recruiting | USA | 0 |
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