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

NCT01489826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-02-09

Study results available
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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

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.

Sponsors & Collaborators

  • e-Therapeutics PLC

    lead INDUSTRY

Principal Investigators

  • Ruth Plummer, MD · Northern Centre for Cancer Care, Freeman Hospital, Newcastle-upon-Tyne, UK

  • Alan Anthoney, MD · Leeds Cancer Centre at St. James's University Hospital

  • Jeff Evans, MD · The Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489826 on ClinicalTrials.gov