Combination Therapy in Cancers With Mutations in DNA Repair Genes
Status:
Not yet recruiting
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly
(ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with
manageable toxicity and reasonable efficacy. Emerging evidence suggest that PARPi is an
effective therapeutic strategy in a wider subset of solid tumors that may have defective
homologous recombination (HR) or DNA repair gene mutations. BReast CAncer gene (BRCA),
partner and localizer of BRCA2 (PALB2), and various other DNA repair germline mutations
predispose carriers to cancers of the breast, ovaries, pancreas, prostate and melanoma. A
number of preclinical studies have demonstrated that PARP inhibitors can work as
chemopotentiators. There is significant interest in this combination, and the recommended
phase II dose will be used in the upcoming NCI ComboMatch trial.