ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

Phase 2 Recruiting 120 enrolled University of Birmingham Jazz Pharmaceuticals · collab The Brain Tumour Charity · collab University of Leeds · collab

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start: 2023-02-03
Primary completion: 2026-09
Completion: 2027-04

Publications

Background Bhaskaran D, Savage J, Patel A, Collinson F, Mant R, Boele F, Brazil L, Meade S, Buckle P, Lax S, Billingham L, Short SC. A randomised phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma (ARISTOCRAT): protocol for a multi-centre, double-blind, placebo-controlled trial. BMC Cancer. 2024 Jan 15;24(1):83. doi: 10.1186/s12885-023-11792-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	12 unknown	Other
Background	Temozolomide	Small molecule	200 mg/m2	Oral

ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

Summary

Timeline

Publications

Drugs

Indications