Therapy Detail

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Therapy Name Niraparib
Synonyms
Therapy Description

Zejula (niraparib) binds and inhibits PARP, which may result in accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved as maintenance therapy in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer 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) 22 Zejula (niraparib) binds and inhibits PARP, which may result in accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved as maintenance therapy in patients with recurrent or newly-diagnosed epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy, and in ovarian, fallopian tube, or primary peritoneal cancer that received 3 or more chemotherapies and is homologous recombination deficient as indicated by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and progressed 6 months or more after response to last 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 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
Unknown unknown malignant astrocytoma not applicable Niraparib Preclinical - Cell line xenograft Actionable In a preclinical study, pediatric high grade astrocytoma cell lines treated with Zejula (niraparib) demonstrated decreased cell viability and proliferation in culture, and a small survival benefit in xenograft models (PMID: 26351319). 26351319
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
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
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
Unknown unknown prostate cancer not applicable Niraparib Phase I Actionable In a Phase I trial, Zejula (niraparib) treatment resulted in stable diseases with a median duration of 254 days in 43% (9/21) of patients with castration-resistant prostate cancer (PMID: 23810788; NCT00749502). 23810788
Unknown unknown ovary epithelial cancer not applicable Niraparib FDA approved Actionable In a Phase III trial (NOVA) that supported FDA approval, maintenance therapy with Zejula (niraparib) improved median progression-free survival compared to placebo in germline BRCA mutant (21.0 vs. 5.5 mo., HR=0.27) and germline BRCA wild-type (9.3 vs. 3.9 mo, HR=0.45) patients with recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer, who had a complete or partial response to 2 or more prior platinum therapies (PMID: 27717299; NCT01847274). detail... 27717299
Unknown unknown ovary epithelial cancer not applicable Niraparib FDA approved Actionable In a Phase III trial (PRIMA) that supported FDA approval, maintenance therapy with Zejula (niraparib) significantly improved progression-free survival compared to placebo in homologous-recombination deficient (21.9 vs 10.4 months, HR=0.43, p<0.001) and the overall (13.8 vs 8.2 months, HR=0.62, p<0.001) populations of patients with newly diagnosed advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer who had a response to platinum-based chemotherapy (PMID: 31562799; NCT02655016). 31562799 detail...
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
Unknown unknown ovarian cancer not applicable Niraparib Phase I Actionable In a Phase I clinical trial, Zejula (niraparib) demonstrated safety and preliminary efficacy, resulted in a durable partial response (PR) in 67% (2/3) of patients with plantinum-sensitive high-grade serous ovarian cancer, PR in 16% (3/19) and stable disease over 120 days in 16% (3/19) of patients with plantinum-resistant high-grade serous ovarian cancer (PMID: 23810788; NCT00749502) 23810788

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03207347 Phase II Niraparib A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) 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
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) Active, not recruiting USA | CAN 12
NCT04641247 Phase II Niraparib A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study 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 Active, not recruiting USA | CAN 0
NCT03359850 Phase I Niraparib Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients Completed USA 0
NCT03553004 Phase II Niraparib Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial Recruiting USA 0
NCT04655183 Phase Ib/II Niraparib + VX-803 Niraparib Study of M4344 in Combination With Niraparib Not yet recruiting USA | 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) Recruiting 4
NCT01847274 Phase III Niraparib A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer Active, not recruiting USA | CAN 13
NCT04592237 Phase II Niraparib Cabazitaxel + Carboplatin + JNJ-63723283 JNJ-63723283 + Niraparib Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer Recruiting USA 0
NCT03329937 Phase I Niraparib Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment Completed USA 0
NCT03644342 Phase Ib/II Niraparib Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix (NIVIX) 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 Active, not recruiting USA | CAN 13
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 Recruiting USA 0
NCT03925350 Phase II Niraparib Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation 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 Recruiting 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 | CAN 17
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 Active, not recruiting USA 0
NCT04584255 Phase II Dostarlimab-gxly + Niraparib Niraparib Niraparib + TSR042 In BRCA Mutated Breast Cancer Recruiting USA 0
NCT02354131 Phase Ib/II Niraparib Bevacizumab + Niraparib Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer (AVANOVA) Active, not recruiting USA 1
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
NCT02500901 Phase I Niraparib Enzalutamide Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) Terminated USA 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
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 | CAN 18
NCT03601923 Phase II Niraparib Niraparib in Patients With Pancreatic Cancer Recruiting USA 0
NCT03016338 Phase II Niraparib Study of Niraparib in Recurrent Endometrial Cancer Active, not recruiting CAN 0
NCT04080284 Phase II Niraparib Trial of Maintenance With Niraparib- Uterine Serous Carcinoma Recruiting USA 0


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