Phase 1B Study of Dexanabinol in Glioblastoma Multiforme Patients
Research type
Research Study
Full title
A Phase Ib Study to assess the Safety and Anti-Tumour Activity of Dexanabinol given in Combination with Temozolomide and Radiation Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme
IRAS ID
180140
Contact name
Mazhar Ajaz
Contact email
Sponsor organisation
e-Therapeutics plc
Eudract number
2014-001246-17
Duration of Study in the UK
2 years, 1 months, 11 days
Research summary
Glioblastoma is the most common primary malignant brain tumour, affecting people of all ages. It is almost invariably lethal. The average life expectancy is around 15 months with maximal standard treatment.
Previous research with dexanabinol (the study drug) has shown that it can be safely given to humans (on its own). Animal studies have shown anti-cancer effects. This study will now further assess the safety and side effects of dexanabinol given in combination with temozolomide (an established drug) and radiation therapy in people who have glioblastoma. We will also explore whether it improves survival and quality of life in these people.
The study consists of two stages. In stage 1, the highest dose of dexanabinol will be determined that is safe for people to take in combination with temozolomide and radiation therapy, and with temozolomide alone. Other studies have already indicated the highest safe dose of dexanabinol when it is given without any other treatments. The main purposes of stage 2 are to look further at the safety and side effects of the study drug in combination with temozolomide and radiation therapy and with temozolomide alone, and to see whether it is effective when it is given alongside these treatments to people who have newly diagnosed glioblastoma.
In all parts of the study, participants will visit the study sites on each dosing day (weekly) for clinical examination and laboratory tests. Participants will also have assessments of tumour size by MRI scans at intervals during the study.
The study is sponsored by e-Therapeutics plc. This means that e-Therapeutics is developing this new treatment, organising this research study, and covering all related costs. The study is taking place at approximately 20 sites in the UK, Germany, and the US. Overall up to 43 participants will enroll.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/1278
Date of REC Opinion
28 Sep 2015
REC opinion
Further Information Favourable Opinion