Conditions: Solid Tumour
Keywords: Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 2: Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 3: Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 4: Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 5: Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 6: Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 7: Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 8: Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.) arm 9: Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)

Interventions: intervention 1: Dexanabinol intervention 2: Cremophor
Intervention descriptions: intervention 1: 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. intervention 2: Drug vehicle.

Protocol document: