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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.
Full description
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.
Enrollment
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Inclusion criteria
Parameters Laboratory Value
Serum total bilirubin :
300mg initial dosing: ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN 200mg initial dosing: up to 3 ULN
-- ASAT and ALAT : 300mg initial dosing: ≤ 2.5 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration) 200mg initial dosing up to 5ULN
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
28 participants in 1 patient group
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Central trial contact
Philippe CASSIER, MD
Data sourced from clinicaltrials.gov
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