NCT01489826

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: e-Therapeutics PLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumour

Interventions

Type	Name	Description
DRUG	Dexanabinol	Patients will (initially) be given a slow intravenous (i.v.) infusion of Dexanabinol over 3 hours on Days 1, 8 and 15 of a three weekly (21 day) cycle.
OTHER	Cremophor	Drug vehicle.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-12-12
• Last updated: 2017-02-09
• Results posted: 2016-10-18

Locations

3 sites across 1 country: United Kingdom