Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388733
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-24
Brief Title:
A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed MGMT Unmethylated Glioblastoma
Sponsor:
Ivy Brain Tumor Center
Organization:
NeuroTrials LLC
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 questions it aims to answer are
Does niraparib improve progression-free survival PFS compared to TMZ
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
Does niraparib improve progression-free survival PFS compared to TMZ
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None