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

NCT05442749 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05442749 on ClinicalTrials.gov