NCT05442749

Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-28
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2022-07-05
• Last updated: 2026-02-17

Locations

4 sites across 1 country: France