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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01489826
Other study ID # ETS2101-001
Secondary ID
Status Completed
Phase Phase 1
First received December 7, 2011
Last updated August 3, 2015
Start date January 2012

Study information

Verified date August 2015
Source e-Therapeutics PLC
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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 nonpsychotropic cannabinoid derivative which was initially developed as a neuroprotective agent due to its antiinflammatory 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 networks that prevent cancer cells dying.


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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexanabinol
Patients will (initially) be given a slow infusion (IV) of Dexanabinol over 3 hours on Days 1, 8 and 15 of a three weekly (21 day) cycle

Locations

Country Name City State
United Kingdom The Beatson West of Scotland Cancer Centre, Glasgow
United Kingdom Leeds Cancer Centre at St. James's University Hospital Leeds England
United Kingdom Northern Centre for Cancer Care, Freeman Hospital, Newcastle-upon-Tyne, UK Newcastle-upon-Tyne Tyne and Wear

Sponsors (1)

Lead Sponsor Collaborator
e-Therapeutics PLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the MTD (highest dose it is safe to give patients) or alternatively the Maximum Administered Dose(MAD).
3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first 3 doses followed by observation through to Day 22, and no Dose Limiting Toxicity (DLT) has occurred.
DLTs will be graded for severity based on the NCI Common Terminology Criteria version 4.03
Each patient will be followed for 22 days Yes
Secondary Area Under Curve (AUC) of Dexanabinol and Cremophor Cycle1- Day 1 and 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion. Day 15: immediately prior to infusion and at the end of infusion. No
Secondary Maximum Concentration (Cmax) of Dexanabinol and Cremophor Cycle1 - Day 1 and 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion. Day 15: immediately prior to infusion and at the end of infusion. No
Secondary Minimum Concentration (Cmin) of Dexanabinol and Cremophor Cycle 1 - Day 1 and 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion. Day 15: immediately prior to infusion and at the end of infusion. No
Secondary Number of adverse events (AEs) AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials 30 +/-3 days from the end of the last infusion Yes
Secondary Tumour response Tumour response evaluation using RECIST 1.1. (Assessment by CT scan or MRI). An additional scan will be performed to confirm a Complete Response (CR) or Partial Response (PR). Tumour markers may be evaluated where appropriate At Screening and after every 2 cycles of treatment (+/-1 week) No
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