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

NCT02423239 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2016-04-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • e-Therapeutics PLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Germany
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02423239 on ClinicalTrials.gov