Status: Not yet recruiting
Niraparib and Temozolomide in Patients Glioblastoma
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.
Participants needed: 86
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Armando Santoro, MDUpdated: Aug 30, 2024Locations: 1
Eligibility criteria
At least 18 years of age. [+11]
Any serious or uncontrolled medical disorder that, in the opinion of the investi... [+23]