Therapy Detail

Therapy Name Niraparib
Therapy Description

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

  • Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.

Drug Name Trade Name Synonyms Drug Classes Drug Description
Niraparib Zejula MK4827 PARP Inhibitor (Pan) 17 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRCA1 mutant breast cancer predicted - sensitive Niraparib Phase I Actionable In a Phase I clinical trial, Zejula (niraparib) was well-tolerated and demonstrated preliminary efficacy in advanced solid tumor patients, including partial responses in 50% (2/4) of breast cancer patients carrying BRCA1 or BRCA2 mutations (PMID: 23810788). 23810788
Unknown unknown ovarian cancer not applicable Niraparib Phase I Actionable In a Phase I clinical trial, Zejula (niraparib) demonstrated safety and efficacy in ovarian cancer patients carrying BRCA1/2 mutations, and in patients with sporadic high-grade serous ovarian cancer (PMID: 23810788). 23810788
Unknown unknown ovarian 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 patients with platinum-sensitive, recurrent ovarian cancer harboring germline BRCA mutations (21.0 vs. 5.5 mo., HR=0.27) and patients without germline BRCA mutations (9.3 vs. 3.9 mo, HR=0.45) (PMID: 27717299; NCT01847274). 27717299
BRCA1 wild-type BRCA2 wild-type ovarian cancer predicted - sensitive Niraparib Phase III Actionable In a Phase III trial (NOVA), Zejula (niraparib) maintenance therapy improved median progression-free survival compared to placebo (9.3 vs. 3.9 months, HR=0.45) in platinum-sensitive, recurrent ovarian cancer patients without germline BRCA mutations, with and without homologous recombination deficiency (12.9 vs. 3.8 months, HR=0.38) (PMID: 27717299; NCT01847274). 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
BRCA1 mutant ovarian cancer predicted - sensitive Niraparib Phase III Actionable In a Phase III trial (NOVA), maintenance Zejula (niraparib) therapy significantly improved median progression-free survival compared to placebo (21.0 vs. 5.5 months, HR=0.27) in patients with platinum-sensitive, recurrent ovarian cancer harboring germline BRCA mutations (PMID: 27717299; NCT01847274). 27717299
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
BRCA2 mutant ovarian cancer predicted - sensitive Niraparib Phase III Actionable In a Phase III trial (NOVA), maintenance Zejula (niraparib) therapy significantly improved median progression-free survival compared to placebo (21.0 vs. 5.5 months, HR=0.27) in patients with platinum-sensitive, recurrent ovarian cancer harboring germline BRCA mutations (PMID: 27717299; NCT01847274). 27717299
Unknown unknown prostate cancer not applicable Niraparib Phase I Actionable In a Phase I clinical trial, Zejula (niraparib) demonstrated antitumor activity in patients advanced solid tumors, including patients with prostate cancer (PMID: 23810788) 23810788
BRCA1 inact mut ovarian cancer sensitive Niraparib Phase I Actionable In a Phase I clinical trial, Zejula (niraparib) demonstrated safety and efficacy in ovarian cancer patients with BRCA1 inactivating mutations (PMID: 23810788). 23810788
Clinical Trial Phase Therapies Title Recruitment Status
NCT03016338 Phase II Niraparib Study of Niraparib in Recurrent Endometrial Cancer 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
NCT03329937 Phase I Niraparib Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment Recruiting
NCT03329001 Phase I Niraparib Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Compared to Niraparib Capsule Recruiting
NCT01847274 Phase III Niraparib A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer Completed
NCT02354131 Phase Ib/II Niraparib Bevacizumab + Niraparib Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer (AVANOVA) Active, not 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
NCT03553004 Phase II Niraparib Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial Recruiting
NCT03601923 Phase II Niraparib Niraparib in Patients With Pancreatic Cancer Recruiting
NCT02500901 Phase I Niraparib Enzalutamide Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) Terminated
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 Recruiting
NCT03359850 Phase I Niraparib Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients Recruiting
NCT03602859 Phase III Niraparib + TSR-042 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
NCT01905592 Phase III Niraparib A Phase III Trial of Niraparib Versus Physician's Choice in Her2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients Active, not 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
NCT02854436 Phase II Niraparib An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies Recruiting