A Phase 3, Open-label, Randomized 2-arm Study Comparing the Clinical Efficacy and Safety of Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

NCT06388733 Phase 3 RECRUITING

The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main question it aims to answer is: Does niraparib improve overall survival (OS) compared to TMZ? Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. * study drug (Niraparib) or * comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. Participants' tasks will include: * Complete study visits as scheduled * Complete a diary to record study medication

Details

Lead sponsor	Ivy Brain Tumor Center
Phase	Phase 3
Status	RECRUITING
Enrolment	450
Start date	2024-06-19
Completion	2028-03

Conditions

• Glioblastoma
• GBM
• Brain Neoplasms, Adult, Malignant
• Brain Tumor

Interventions

• Niraparib
• Temozolomide

Primary outcomes

• Overall survival — 24 months
  Overall survival, defined as the time from the date of randomization to the date of death due to any cause.

Countries

United States, Australia, Canada, France, Germany, Italy, Netherlands, Norway, Spain, Switzerland, United Kingdom