ID:5
Study Name:PARADIGM-2
Iras Number:197457
Study Type:Interventional
Anatomical Region:Head and Neck
Disease Site:Brain
Study Status:Open
Site Location:
The Christie NHS Foundation Trust
Wilmslow Road, Manchester, M20 4BX
Full Study Title:
OlaPArib and RADIotherapy or olaparib and radiotherapy plus temozolomide in newlydiagnosed Glioblastoma stratified by MGMT status: 2 parallel phase I studies
Research Summary:
The main questions this research is trying to answer are:
Group 1 (MGMT‑methylated tumours)
For patients whose glioblastoma has a certain marker called MGMT methylation, the study aims to find out:
- Whether it is safe to take a drug called olaparib alongside radiotherapy and the chemotherapy drug temozolomide.
- What side effects this combination might cause.
- What the most suitable dose of olaparib should be for future research.
Group 2 (MGMT‑unmethylated tumours)
For patients whose glioblastoma does not have MGMT methylation, the study aims to find out:
- Whether it is safe to take olaparib together with radiotherapy.
- What side effects this combination might cause.
- What the best dose of olaparib should be for future research.
*MGMT is a gene which helps to repair damage to DNA. "Methylation" is a natural chemical change that can switch a gene off or reduce how strongly it works.
MGMT-methylated tumours mean the MGMT gene is less active, so it cant repair the chemotherapy damage as well = temozolomide is more likely to work better.
MGMT-unmethylated tumours mean the MGMT gene is more active, so it repairs damage more easily = temozolomide may be less effective.
**Patients will require a methylation test of their tumour prior to enrolling on the study.
Contact Information:
Date Site Open:
APR
12
2017
Study End Date:
JUN
30
2026
Randomisation
Additional Appointments
Link to NIHR Database:
Not provided