NCT01654497

A Phase I, Sequential Cohort, Open-Label, Dose-escalation Study of the Safety and CNS Pharmacokinetics of Dexanabinol in Patients With Brain Cancer

Completed Phase 1 Last updated 12 November 2019

What this trial tests

Phase 1 trial testing Dexanabinol in Brain Cancer in 26 participants. Completed in 1 July 2017.

Timeline

1 June 2012

Primary endpoint
1 September 2015

1 July 2017

Quick facts

Lead sponsor	Santosh Kesari, M.D., Ph.D.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	1 June 2012
Primary completion	1 September 2015
Estimated completion	1 July 2017
Sites	1 location across United States

Drugs / interventions tested

• Dexanabinol — full drug profile →

Conditions studied

• Brain Cancer — all drugs for Brain Cancer →

Sponsor

Santosh Kesari, M.D., Ph.D.

Who can join

18 and older, any sex, with Brain Cancer. 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.

• Rate of dose limiting toxicities and the maximum tolerated dose (MTD) of weekly dexanabinol
  Time frame: first 28 days of treatment

Sponsor's own description

The purpose of this study is to try to determine the maximum safe dose of dexanabinol that can be administered to people with brain cancer. Other purposes of this study are to:

* find out what effects (good and bad) dexanabinol has;
* see how much drug gets into the body by collecting blood and cerebrospinal fluid for use in pharmacokinetic (PK) studies;
* learn more about how dexanabinol might affect the growth of cancer cells;
* look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug).

Publications & conference data

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

1. Current Challenges and Opportunities in Treating Glioblastoma.
   Shergalis A, Bankhead A, Luesakul U, Muangsin N, et al · · 2018 · cited 612× · PMID 29669750 · DOI 10.1124/pr.117.014944
2. 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
3. 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
4. NF-κB and STAT3 in glioblastoma: therapeutic targets coming of age.
   Gray GK, McFarland BC, Nozell SE, Benveniste EN. · · 2014 · cited 87× · PMID 25262780 · DOI 10.1586/14737175.2014.964211
5. 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
6. 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
7. Amino acid metabolism in glioblastoma pathogenesis, immune evasion, and treatment resistance.
   Srivastava S, Anbiaee R, Houshyari M, Laxmi, et al · · 2025 · cited 15× · PMID 40082966 · DOI 10.1186/s12935-025-03721-1
8. Systems Pharmacology Modeling Identifies a Novel Treatment Strategy for Bortezomib-Induced Neuropathic Pain.
   Bloomingdale P, Meregalli C, Pollard K, Canta A, et al · · 2021 · cited 8× · PMID 35126148 · DOI 10.3389/fphar.2021.817236