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) 19 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
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
Unknown unknown 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
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 (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...
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
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

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Clinical Trial Phase Therapies Title Recruitment Status
NCT04037254 Phase II Niraparib Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer Recruiting
NCT03601923 Phase II Niraparib Niraparib in Patients With Pancreatic Cancer Recruiting
NCT03329001 Phase I Niraparib Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Compared to Niraparib Capsule Active, not recruiting
NCT03359850 Phase I Niraparib Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients Active, not recruiting
NCT02354131 Phase Ib/II Niraparib Bevacizumab + Niraparib Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer (AVANOVA) Active, not recruiting
NCT03308942 Phase II Niraparib Phase 2, Multi-Arm Study of Niraparib Administered Alone and in Combination With PD-1 Inhibitor in Patients With Non-Small Cell Lung Cancer Active, not recruiting
NCT03329937 Phase I Niraparib Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment Active, not recruiting
NCT04288687 Phase II Niraparib A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects Not yet recruiting
NCT03016338 Phase II Niraparib Study of Niraparib in Recurrent Endometrial Cancer Recruiting
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
NCT03553004 Phase II Niraparib Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial Recruiting
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
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
NCT03945721 Phase I Niraparib A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Patients With Triple Negative Breast Cancer and an Incomplete Pathologic Response Recruiting
NCT02854436 Phase II Niraparib An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies Recruiting
NCT03207347 Phase II Niraparib A Trial of Niraparib in BAP1 and Other DNA Double-Strand Break Repair Deficient Neoplasms (UF-STO-ETI-001) Recruiting
NCT04221503 Phase II Niraparib Niraparib/TTFields in GBM Active, not recruiting
NCT04080284 Phase II Niraparib Trial of Maintenance With Niraparib- Uterine Serous Carcinoma Recruiting
NCT03644342 Phase Ib/II Niraparib Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix (NIVIX) Recruiting
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
NCT04030559 Phase II Niraparib Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects Recruiting
NCT03925350 Phase II Niraparib Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation Recruiting
NCT01847274 Phase III Niraparib A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer Active, not recruiting
NCT03602859 Phase III Dostarlimab + 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) Recruiting
NCT02500901 Phase I Niraparib Enzalutamide Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) Terminated


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