Niraparib and Temozolomide in Patients Glioblastoma (NCT06258018) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Niraparib and Temozolomide in Patients Glioblastoma
Italy86 participantsStarted 2024-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age.
✓. Ability to understand and willingness to sign an ethics committee approved written informed consent document (or that of legally authorized representative, if applicable).
✓. Patients with diagnosis of recurrent\\progressive IDH wild-type GBM (WHO 2021, grade 4). All the GBM histological variants are allowed.
✓. Patients with diagnosis of recurrent/progressive IDH mutant gliomas (WHO 2021, grade 2-4). Both astrocytoma and oligodendroglioma may be included.
✓. Both MGMT methylated and unmethylated patients are allowed.
✓. Unequivocal evidence of tumor progression with at least one target lesion based on MRI scan according to Response Assessment in Neuro-Oncology criteria (RANO) or low-grade gliomas (LGGs) Response Assessment in Neuro-Oncology (RANO) criteria for non-enhancing tumors
✓. Patients with IDH wild-type GBM (WHO grade 4) must have received at least the standard front-line therapy defined as below:
✓. Patients with IDH mutant gliomas (WHO 2021 grade 2-4, both astrocytoma and oligodendroglioma may be included) must have received at least:
Exclusion criteria
✕. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive the planned therapy (including brain surgery), or interfere with the interpretation of study results.
. Anticancer treatment within the last 14 days before the start of trial treatment, for example chemotherapy, radiotherapy, immunotherapy. A shorter interval can be approved by the principal investigator, if deemed appropriate.
✕. Presence of diffuse and unequivocal leptomeningeal or extra-cranial disease.
✕. Steroid therapy with dexamethasone \> 4 mg daily.
✕. Chronic (at least 4 weeks) use of drugs with known risk of QT prolongation.
✕. Use of anticoagulant agents at therapeutic dose (e.g. Low-molecular-weight heparin ( LWMH), new anti-coagulation oral drug (NAO) , Warfarin). Prophylactic dose is allowed. Antiplatelet agents are allowed.