ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

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).

Trial Details

NCT ID
NCT05629702
Phase
PHASE2
Sponsor
University of Birmingham
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Nabiximols
  • Temozolomide
  • Nabiximols-matched placebo
Locations (sample)
  • Bodelwyddan, Denbighshire, United Kingdom|53.26827,-3.50078
  • Northwood, Middlesex, United Kingdom|51.61162,-0.42454
  • Aberdeen, United Kingdom|57.14369,-2.09814
  • Belfast, United Kingdom|54.59682,-5.92541
  • Birmingham, United Kingdom|52.48142,-1.89983

Key Eligibility Criteria

  • Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence i…
  • First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant Neu…
  • Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e. 40 Gy in 15 fractions or…
  • A minimum of 3 cycles of adjuvant TMZ must have been received.

For full eligibility, visit ClinicalTrials.gov.

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