NCT01489826

A Phase 1, Pharmacokinetically-Guided, Dose Escalation Study to Assess the Safety and Tolerability of Dexanabinol in Patients With Advanced Solid Tumours

Completed Phase 1 Results posted Last updated 16 December 2016

What this trial tests

Phase 1 trial testing Dexanabinol in Solid Tumour in 40 participants. Completed in 1 July 2015.

Timeline

1 January 2012

Primary endpoint
1 July 2015

1 July 2015

Quick facts

Lead sponsor	e-Therapeutics PLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 January 2012
Primary completion	1 July 2015
Estimated completion	1 July 2015
Sites	3 locations across United Kingdom

Drugs / interventions tested

• Dexanabinol — full drug profile →
• Cremophor

Conditions studied

• Solid Tumour — all drugs for Solid Tumour →

Sponsor

e-Therapeutics PLC — full company profile →

Who can join

18 and older, any sex, with Solid Tumour. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients Experiencing Dose Limiting Toxicity (DLT)
  Time frame: Each patient will be followed for 22 days
  Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the maximum tolerated dose (MTD) (highest dose it is safe to give patients) or alternatively the maximum administered dose (MAD). 3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed t

Sponsor's own description

This study is a trial of Dexanabinol in patients with advanced solid tumours. The purposes of this protocol are to study different doses of the study drug to determine the maximum safe dose and to further understand the safety of the study drug; to understand what the body does to the study drug; to understand what the study drug does to the body and to measure any reduction in size of patients' cancer tumour(s).

Dexanabinol is a synthetic cannabinoid derivative with reduced psychotropic potential which was initially investigated as a neuroprotective agent. Because of its method of action however it is thought that it may have the effect of destroying cancer cells by reducing the level of control on networks that prevent cancer cells dying.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The current state and future perspectives of cannabinoids in cancer biology.
   Śledziński P, Zeyland J, Słomski R, Nowak A. · · 2018 · cited 100× · PMID 29473338 · DOI 10.1002/cam4.1312
2. The Endocannabinoid System as a Target in Cancer Diseases: Are We There Yet?
   Moreno E, Cavic M, Krivokuca A, Casadó V, et al · · 2019 · cited 95× · PMID 31024307 · DOI 10.3389/fphar.2019.00339
3. Cannabinoids in the landscape of cancer.
   Mangal N, Erridge S, Habib N, Sadanandam A, et al · · 2021 · cited 72× · PMID 34259916 · DOI 10.1007/s00432-021-03710-7
4. Cannabinoids as anticancer therapeutic agents.
   Kovalchuk O, Kovalchuk I. · · 2020 · cited 53× · PMID 32249682 · DOI 10.1080/15384101.2020.1742952
5. A user's guide to cannabinoid therapies in oncology.
   Maida V, Daeninck PJ. · · 2016 · cited 45× · PMID 28050136 · DOI 10.3747/co.23.3487
6. Can Hemp Help? Low-THC Cannabis and Non-THC Cannabinoids for the Treatment of Cancer.
   Afrin F, Chi M, Eamens AL, Duchatel RJ, et al · · 2020 · cited 40× · PMID 32340151 · DOI 10.3390/cancers12041033
7. Use of Cannabis and Cannabinoids for Treatment of Cancer.
   Cherkasova V, Wang B, Gerasymchuk M, Fiselier A, et al · · 2022 · cited 28× · PMID 36291926 · DOI 10.3390/cancers14205142
8. Cannabinoids in Breast Cancer: Differential Susceptibility According to Subtype.
   Almeida CF, Teixeira N, Correia-da-Silva G, Amaral C. · · 2021 · cited 26× · PMID 35011388 · DOI 10.3390/molecules27010156