drugset / Trial / NCT01654497

Dexanabinol in Patients With Brain Cancer

NCT01654497

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to try to determine the maximum safe dose of dexanabinol that can be administered to people with brain cancer. Other purposes of this study are to: * find out what effects (good and bad) dexanabinol has; * see how much drug gets into the body by collecting blood and cerebrospinal fluid for use in pharmacokinetic (PK) studies; * learn more about how dexanabinol might affect the growth of cancer cells; * look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug).

Timeline

Start
2012-06
Primary completion
2015-09
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexanabinol Small molecule 2 mg/kg Intravenous
Subject Dexanabinol Small molecule 4 mg/kg Intravenous
Subject Dexanabinol Small molecule 8 mg/kg Intravenous
Subject Dexanabinol Small molecule 16 mg/kg Intravenous
Subject Dexanabinol Small molecule 24 mg/kg Intravenous
Subject Dexanabinol Small molecule 28 mg/kg Intravenous
Subject Dexanabinol Small molecule 36 mg/kg Intravenous
Subject Dexanabinol Small molecule 40 mg/kg Intravenous
Subject Dexanabinol Small molecule 44 mg/kg Intravenous

Indications