Overview

Niraparib and Temozolomide in Patients Glioblastoma

Status:
NOT_YET_RECRUITING
Trial end date:
2027-09-01
Target enrollment:
Participant gender:
Summary
The study evaluates safety, tolerability, pharmacokinetics at recommended phase II dose (RP2D) and preliminary antitumor activity of Niraparib + dd-TMZ "one week on, one week off" in patients affected by recurrent GBM IDH wild-type and recurrent IDH mutant (WHO grade 2-4) gliomas. The treatment will be administered until progressive disease, unacceptable toxicity, consent withdrawal, lost to follow-up or death. The entire study is expected to last approximately 40 months.
Phase:
PHASE1
Details
Lead Sponsor:
Armando Santoro, MD
Collaborators:
GlaxoSmithKline
Istituto Clinico Humanitas
Treatments:
niraparib
Temozolomide