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Niraparib and Temozolomide in Patients Glioblastoma

NCT06258018 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-08-30

No results posted yet for this study

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.

Conditions

  • Glioma, Malignant

Interventions

DRUG

Temodal

given orally for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days

DRUG

Niraparib

given orally in continous

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Armando Santoro, MD

    lead OTHER

Principal Investigators

  • Matteo Simonelli, MD · Istituto Clinico Humanitas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2026-12-31
Completion
2027-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT06258018 on ClinicalTrials.gov