Phase 1b Study of Dexanabinol in Advanced Cancer
Research type
Research Study
Full title
A Phase 1b Study to Assess the Safety and Anti-tumour Activity of Dexanabinol Monotherapy and Dexanabinol in Combination with Chemotherapy in Patients with Advanced Tumours
IRAS ID
168243
Contact name
Ruth Plummer
Contact email
Sponsor organisation
e-Therapeutics plc
Eudract number
2014-004342-99
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 0 days
Research summary
This study is a trial of an investigational drug called 'dexanabinol' in participants with advanced solid tumours.
The purposes of this protocol are to determine the maximum safe dose and to further understand the safety of the study drug (with and without standard chemotherapy). Dexanabinol is a synthetic cannabinoid derivative (which means that it is prepared in the laboratory through chemical processes).
Analysis of this drug suggests that it could have an anti-cancer effect; 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.Participants may be enrolled into 3 different parts of the study; dexanabinol will be given in combination with standard chemotherapy (part 1 and 2b) or on its own (part 2a). Approximately 112 participants (aged 18 and over) with advanced solid tumours will be enrolled in the study from across approximately 20 sites, globally. Additional sites may be added if necessary to meet enrolment targets.
Participants will be given a slow infusion of dexanabinol over 1-3 hours on Days 1, 8, 15 and 22 of a four weekly (28 day) cycle and will undergo regular examinations, blood tests and scans to assess safety of the drug and the size of their tumour. Participants will be treated for 6 cycles as long as their cancer does not grow.
Further cycles of treatment may be given to participants whose cancer has responded to treatment after 6 cycles, this will be at the discretion of the investigator and the sponsor. The final study visit for patients will be performed at the clinic, approximately 30 days after their last administered dose of dexanabinol; a number of examinations will be performed at the final visit.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0017
Date of REC Opinion
25 Feb 2015
REC opinion
Further Information Favourable Opinion