NCT02423239

A Study of Dexanabinol in Combination With Chemotherapy in Patients With Advanced Tumours

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• 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 tumours. The purposes of the protocol are to study different doses of the study drug to determine the maximum safe dose of the drug given in combination with standard chemotherapies and to further understand the safety of the study drug and to measure any reduction in size of patients' cancer tumour(s). Dexanabinol is a synthetic cannabinoid which has previously undergone clinical trials for traumatic brain injury (TBI) and in subjects undergoing coronary artery bypass surgery. Currently dexanabinol is under investigation for potential anti-tumour activity in patients with advanced tumours.

Conditions

• Hepatocellular Carcinoma
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Dexanabinol	Patients will receive dexanabinol given once a week, as a slow intravenous infusion (i.v.) over a 3 hour period
DRUG	Sorafenib	Patients will receive Sorafenib at a dose of 400 mg bid (oral administration)
DRUG	Nab-paclitaxel	Patients will receive Nab-paclitaxel at a dose of 125mg/m2 intravenous infusion
DRUG	Gemcitabine	Patients will receive Gemcitabine at a dose of 1000mg/m2 intravenous infusion

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-04-22
• Last updated: 2016-04-06

Locations

13 sites across 4 countries: Germany, Poland, Spain, United Kingdom