Table 9. Niraparib as monotherapy and in combination therapy.
Clinical trial | Phase | N | Study objective | Germline mutations | Somatic mutations | PFS | OS | ORR |
Niraparib monotherapy | ||||||||
NCT03601923 [57] | II | Proof-of-concept trial evaluating niraparib in patients with HRD pancreatic cancer progressed on one line of therapy except platinum agents | Germline and somatic mutations in BRCA1, BRCA2, PALB2, CHEK2, or ATM | Currently enrolling | ||||
NCT03553004 NIRA-PANC [58] | II | Efficacy in metastatic pancreatic cancer patients with HRD mutations who received at least one prior line of therapy. | Germline and somatic HRD mutations | Currently enrolling | ||||
Niraparib with immunotherapy | ||||||||
NCT03404960 Parpvax [59] | Ib/II | Study of niraparib plus either ipilimumab or nivolumab in patients with advanced pancreatic cancer whose disease has not progressed on platinum-based therapy | HRD will be identified after enrollment | Currently enrolling. |