Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05629702
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2022-11-07
Brief Title:
ARISTOCRAT Blinded Trial of Temozolomide - Cannabinoids
Sponsor:
University of Birmingham
Organization:
University of Birmingham
Study Overview
Official Title:
A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent 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:
ARISTOCRAT
Brief Summary:
ARISTOCRAT is a phase II multi-centre double-blind placebo-controlled randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma GBM treated with temozolomide TMZ
Detailed Description:
This is a phase II multi-centre double-blind placebo-controlled randomised trial to compare the cannabinoid Nabiximols Sativex with placebo in patients with recurrent MGMT methylated glioblastoma treated with temozolomide TMZ The trial will randomise a target number of 234 patients on a 21 basis to receive either Nabiximols or Nabiximols-matched placebo in combination with standard TMZ
Patients will be followed up at 4-weekly assessments for a minimum of 52 weeks from the start of trial treatment or until death whichever is sooner MRI scanning will be performed at screening week 10 week 22 week 30 then 3-monthly after commencing trial treatment as per standard practice
The trial includes an initial feasibility study of 40 patients to confirm safety compliance and achievability of planned target recruitment There are no formal criteria for evaluation of feasibility but once 40 patients have been recruited the independent Data Monitoring Committee will review the adverse event data details on protocol treatment received monthly recruitment rates and projected recruitment in order to make recommendations on trial continuation
The current phase II trial design will enable potential expansion of recruitment into a phase III trial should the emerging phase II results warrant this development
The trial will be linked to the Tessa Jowell BRAIN MATRIX TJBM programme utilising TJBM infrastructure opening the same participating sites and aligning the data collection and Quality of Life assessments already embedded in TJBM This collaboration will allow data sharing within the platform thereby streamlining patient entry and provide additional oversight through TJBM Patients recruited to TJBM who are potentially eligible for ARISTOCRAT may be identified and suggested to sites for consideration to the trial
Patients will be followed up at 4-weekly assessments for a minimum of 52 weeks from the start of trial treatment or until death whichever is sooner MRI scanning will be performed at screening week 10 week 22 week 30 then 3-monthly after commencing trial treatment as per standard practice
The trial includes an initial feasibility study of 40 patients to confirm safety compliance and achievability of planned target recruitment There are no formal criteria for evaluation of feasibility but once 40 patients have been recruited the independent Data Monitoring Committee will review the adverse event data details on protocol treatment received monthly recruitment rates and projected recruitment in order to make recommendations on trial continuation
The current phase II trial design will enable potential expansion of recruitment into a phase III trial should the emerging phase II results warrant this development
The trial will be linked to the Tessa Jowell BRAIN MATRIX TJBM programme utilising TJBM infrastructure opening the same participating sites and aligning the data collection and Quality of Life assessments already embedded in TJBM This collaboration will allow data sharing within the platform thereby streamlining patient entry and provide additional oversight through TJBM Patients recruited to TJBM who are potentially eligible for ARISTOCRAT may be identified and suggested to sites for consideration to the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005214-34 | EUDRACT_NUMBER | None | None |
| ISRCTN | REGISTRY | ISRCTN11460478 | None |