Niraparib and Temozolomide in Patients Glioblastoma
ConditionGlioma, Malignant
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArmando Santoro, MD
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Previous G4 hematological toxicity (anemia, neutropenia, thrombocytopenia) during concomitant and/or adjuvant TMZ treatment.
Previous treatment with a PARP inhibitor.
Trial design
Treatments tested in this trial
- Temodal
- Niraparib
Treatment groups
86 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Armando Santoro, MD
Lead sponsor
Istituto Clinico Humanitas
Sponsor institution
Istituto Clinico Humanitas
Collaborator
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov