Phase 1 Dose Escalation Study of Dexanabinol in Advanced Cancer
Research type
Research Study
Full title
A Phase 1, Pharmacokinetically-Guided, Dose Escalation Study to Assess the Safety and Tolerability of Dexanabinol in Patients with Advanced Solid Tumours
IRAS ID
83452
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
e-Therapeutics PLC
Eudract number
2011-002706-67
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research 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 non-psychotropic cannabinoid derivative which was initially developed as a neuroprotective agent due to its anti-inflammatory activity. 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 pathways that prevent cancer cells dying.Approximately 45 patients aged 18 and over with advanced solid tumours will be enrolled in the study at 2 NHS trusts within the UK. Additional sites may be added if necessary to meet enrolment targets. Patients will (initially) be given a slow infusion of Dexanabinol over 3 hours on Days 1, 8 and 15 of a three weekly (21 day) cycle and will undergo regular examinations, blood tests and scans to assess safety of the drug and the size of their tumour. Patients will be treated for 6 cycles as long as their cancer does not grow. Further cycles of treatment may be given to patients whose cancer has responded to treatment after 6 cycles, this will be at the discretion of the investigator and the sponsor.
REC name
North West - Haydock Research Ethics Committee
REC reference
11/NW/0606
Date of REC Opinion
12 Oct 2011
REC opinion
Further Information Favourable Opinion