Start Date
October 28, 2022
Primary Completion Date
January 15, 2026
Study Completion Date
September 15, 2026
Niraparib
"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.~300 mg/day, continuously for patients with TB \>1.5- 3 ULN and/or ASAT/ALAT ≤5ULN.~Or 200mg/day initial dosing for patients with TB \>1.5 ULN and up to 3ULN and/or ASAT/ALAT \> 2.5 ULN and up to 5 ULN with increase to 300mg/day if 1) liver safety lab tests improve to Grade 1 according to NCI criteria (based on total bilirubin and AST/ALT) with bilirubin \< 1.5ULN) and 2) no grade \>1 related AE are reported."
Centre Léon Bérard, Lyon
Collaborators (1)
GlaxoSmithKline
INDUSTRY
Centre Leon Berard
OTHER