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.Â
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.Â
**Patients will require a methylation test of their tumour prior to enrolling on the study.Â
Speak to your healthcare team
If you have interest in this study, please discuss this with your oncology healthcare team.
Date Site Open:
APR
12
2017
Study End Date:
JUN
30
2026
Randomisation
Additional Appointments
Link to NIHR Database:
Not provided