CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 120 target
Drug / intervention
Nabiximols +2 moredrug
Likely dose
Not stated in record
Key inclusion· 11
  • ✓Histological diagnosis of MGMT promoter methylated, IDH wild type GBM
  • ✓First recurrence of GBM planned for systemic treatment
  • ✓Prior first-line treatment with standard dose conventionally fractionated radiotherapy with concomitant and adjuvant TMZ
  • ✓Minimum of 3 cycles of adjuvant TMZ
Key exclusion· 19
  • ✕Pathology inconsistent with IDH WT GBM (e.g., PXA or BRAF mutation)
  • ✕Prior invasive malignancy except non-melanoma skin cancer, unless disease-free ≥1 year
  • ✕Prior stereotactic radiotherapy, brachytherapy, or CED
  • ✕Prior treatment apart from debulking surgery for first recurrence

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05629702
NCT05629702Phase 2RecruitingHigh Momentum
Long Recruiting
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A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma

University of Birmingham·interventional·Posted Nov 29, 2022·Updated May 5, 2026

In Brief

A Phase 2 clinical trial evaluating Nabiximols, Temozolomide, and 1 other intervention for Glioblastoma and 3 related conditions. Currently recruiting, targeting 120 participants across 22 sites.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma, Brain Tumor, Cannabis, Brain Tumor, Recurrent
CountriesUnited Kingdom
CollaboratorsUniversity of Leeds, The Brain Tumour Charity, Jazz Pharmaceuticals

Timeline

Phase 2Recruiting
20232024202520262027
First PostedNov 29, 2022
Enrollment StartFeb 3, 2023
Primary CompletionSep 1, 2026
Study CompletionApr 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 3.6 years agoPrimary completion in 2 months

Interventions

Nabiximolsdrug

Oromucosal spray

Temozolomidedrug

Oral capsule

Nabiximols-matched placebodrug

Nabiximols-matched placebo oromucosal spray