5G-Master and 5G-PEARL
Research type
Research Study
Full title
Minderoo 5G: A Next Generation AGile Genomically Guided Glioma Modular Platform for proof-of-concept molecular hypothesis testing in patients with high grade malignant brain tumours and 5G-PEARL: Paxalisib as monotherapy and in combination with Temozolomide in patients with high grade malignant brain tumours within the Minderoo 5G Platform
IRAS ID
1007726
Contact name
Juanita Lopez
Contact email
Sponsor organisation
The Institute of Cancer Research
Research summary
Precision medicine (also known as targeted medicine) is a modern approach to treating patients based upon the individual characteristics of their tumour cells. In this trial, every patient with GBM, will have their tumour cells analysed by molecular profiling to identify their precise molecular flags. The results of these analyses allow the enrolment of patients with a particular flag/flags onto a matched novel drug or combination that has been specifically developed to target these aberrations. In other words, the choice of drug therapy (or treatment) is determined by the characteristics of each patient’s GBM.
This trial uses this precision medicine approach to group patients according to the molecular characteristics of their GBM and test their matched drug in a three-phase approach. The first phase will establish the best dose to use (phase 1a), the second phase will test if the drug shows clinical improvement (phase 1b) and the third phase will assess the effectiveness of the drug (phase 2).
The 5G-PEARL clinical study will investigate an experimental medication called Paxalisib. We are studying Paxalisib to find out if it works
for brain cancers that have a molecular flag or signature indicating it has an overactive PI3K pathway (for example your brain tumour has a PI3K mutation, or has lost a protein called PTEN).REC name
London - Central Research Ethics Committee
REC reference
23/LO/0720
Date of REC Opinion
3 Nov 2023
REC opinion
Further Information Favourable Opinion