GWCA1208 - Study of Sativex in Patients with Recurrent Glioblastoma
Research type
Research Study
Full title
A two part study to assess the tolerability, safety and pharmacodynamics of Sativex in combination with dose-intense Temozolomide in patients with recurrent glioblastoma.
IRAS ID
126242
Contact name
Susan Short
Contact email
Eudract number
2012-004800-37
Clinicaltrials.gov Identifier
Research summary
This study is being conducted by GW Pharma Ltd to determine the tolerability and safety of the drug Sativex® at its Maximum Tolerated Dose (MTD), in combination with Dose-Intense Temozolomide (DIT) in participants with recurrent glioblastoma (GBM).
The first part of the study is an open-label phase followed by a double-blind, randomised, placebo-controlled phase (randomisation phase). Participants enrol into either the open-label or randomisation phase and complete the same visit schedule and procedures. An investigator led Safety Review Team (SRT) will assess the safety profile of the open-label participants at two specified time points and decide whether the study can progress to the start of the randomisation phase. The open-label participants continue in the open-label phase. At this time the open-label phase and the randomisation phase run simultaneously.
The open-label phase will enrol 6 eligible participants who will recieve Sativex along with DIT. The randomisation Phase will enrol 20 eligible participant who will be randomised to receive DIT along with Investigational Medicinal Product (IMP) as either Sativex or placebo using a 1:1 allocation ratio.
All participants confirmed eligible following Visit 1 screening, will begin a DIT regime of 85mg/m2/day for 21 days in each 28 day cycle. Seven days after starting DIT participicants return for Visit 2 whereby participants receive Sativex in the open-label phase or IMP in the randomisation phase. Participants titrate Sativex or IMP for two weeks to find their individual MTD and return one week later for Visit 3. From Visit 3 onwards participants return every two weeks until Visit 7 and then every 4 weeks thereafter until 12 months treatment in the maintenance phase is completed. Participants complete an end of treatment visit at Visit 17 and a telephone follow up visit at Visit 18 4 weeks later.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0126
Date of REC Opinion
19 Jul 2013
REC opinion
Further Information Favourable Opinion