drugset / Trial / NCT01489826

A Phase 1 Study of Dexanabinol in Patients With Advanced Solid Tumours

NCT01489826

Phase 1 Completed 40 enrolled e-Therapeutics PLC
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-01
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexanabinol Small molecule 2 mg/kg Intravenous
Subject Dexanabinol Small molecule 3 mg/kg Intravenous
Subject Dexanabinol Small molecule 6 mg/kg Intravenous
Subject Dexanabinol Small molecule 12 mg/kg Intravenous
Subject Dexanabinol Small molecule 15 mg/kg Intravenous
Subject Dexanabinol Small molecule 22 mg/kg Intravenous
Subject Dexanabinol Small molecule 30 mg/kg Intravenous
Subject Dexanabinol Small molecule 36 mg/kg Intravenous

Indications