Metastatic Pancreatic Cancer Clinical Trial
Official title:
A Multicentric, Single Arm, Phase II Trial Assessing the Efficacy of Niraparib as First Line Therapy for Patients With Metastatic Homologous Repair-deficient Pancreatic Cancer
This trial is a single arm open-label, phase II aiming to assess the clinical activity of niraparib in chemotherapy-naïve biomarker-selected pancreatic cancer patients.
This trial is a single arm open-label, phase II aiming to assess the clinical activity (objective response rate at week16 according to RECIST V1.1) of niraparib in chemotherapy-naïve biomarker-selected pancreatic cancer patients. HR alterations must be confirmed before study drug start: only patients with mutation and/or rearrangement leading to inactivation in at least one of the following genes BARD1, BRCA1, BRCA2, BRIP1, FANCA, FANCD2, FANCL, MRE11, NBN, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L are eligible. Eligible patients will receive niraparib once daily, per os, continuously until loss of clinical benefit, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first. ;
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