Niraparib As First Line Therapy with Metastatic Homologous Repair-deficient Pancreatic Cancer

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 28, 2022

Primary Completion Date

January 15, 2026

Study Completion Date

September 15, 2026

Conditions
Metastatic Pancreatic Cancer
Interventions
DRUG

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."

Trial Locations (1)

Unknown

Centre Léon Bérard, Lyon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Centre Leon Berard

OTHER