Survival Outcomes and Interventions Pre and Post GWCA1208
Research type
Research Study
Full title
Survival Outcomes and Interventions Pre and Post Treatment during the GWCA1208 Trial
IRAS ID
237149
Contact name
Susan Short
Contact email
Sponsor organisation
GW Research Ltd
Duration of Study in the UK
10 years, 4 months, 31 days
Research summary
GWCA1208 was an exploratory trial to determine the tolerability and safety of Δ9 tetrahydrocannabinol (THC) and cannabidiol (CBD) in a 1:1 ration, in combination with dose intense Temozolomide in participants with newly diagnosed recurrent Glioblastoma Multiforme, however it was not formally powered to detect statistical significance of secondary efficacy endpoints.
GWCA17017 Protocol aims to collect additional existing data on the GWCA1208 patients to fully understand the significance of the survival outcomes observed and thus clinical utility of CBD:THC. Specific data on interventions pre and post GWCA1208, investigator opinion of the significance of these interventions on the survival outcome and any outstanding survival data post GWCA1208 will be sought.
Protocol Annex 1: The results of any pre-assessment of subjects’ O6 methylguanine-DNA methyltransferase (MGMT) gene promoter methylation and Isocitrate dehydrogenase (IDH) gene mutation status, will help further explain survival outcomes observed in GWCA1208, as they are extensively documented as related to a more favourable prognosis, this is important in understanding the survival outcomes observed in GWCA1208. This assessment is to be conducted on tumour materials leftover from GWCA1208 only.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0344
Date of REC Opinion
18 May 2018
REC opinion
Favourable Opinion