ClinGlio
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled adjuvant trial in newly diagnosed primary glioblastoma subjects to assess the efficacy and safety of 2-hydroxyoleic acid (2-OHOA) in combination with radiotherapy and temozolomide standard of care treatment
IRAS ID
261755
Contact name
Juanita Lopez
Contact email
Sponsor organisation
Lipopharma Therapeutics
Eudract number
2018-000365-37
Duration of Study in the UK
7 years, 2 months, 1 days
Research summary
This study investigates the efficacy and safety of the therapy with 2-hydroxyoleic acid (2-OHOA) in combination with the standard of care (SoC) treatment of radiotherapy (RT) and Temozolomide (TMZ), compared with SoC alone, in subject with glioblastoma.
2-OHOA is a new class of a synthetic lipid, administered orally, that interacts with cells in your body, causing that cell to die. The effect of 2-OHOA on cell death appears to be restricted to tumour cells. The treatment of cancer patients with 2-OHOA showed objective clinical benefit in several heavily pre-treated refractory advanced solid tumour subjects, including 8 patients with refractory malignant glioma. Further investigations with this study may provide additional information on the effects of 2-OHOA in glioblastoma.
Subjects with a primary diagnosis of glioblastoma may be eligible to participate in the study.
Laboratory and animal tests showed that 2-OHOA is safe to use. The results of a previous study with 2-OHOA in humans show that 2-OHOA has a very good safety profile.
During this study the eligible subjects will be randomized in three arms: Arm A will receive SoC and a placebo; Arm B and Arm C will receive the SoC and low dose and high dose of 2-OHOA respectively. This study is double-blinded, which means that neither the subjects nor the doctors know if 2-OHOA or the placebo is being administered to the subject.
The duration of the trial for each individual subject will depend on the number of treatment cycles and will therefore be variable. During the study the subjects will undergo a screening phase, followed by the SoC during which 2-OHOA/Placebo is additionally administered. After this phase, treatment with 2-OHOA/Placebo may continue until the end of study.
This study is being sponsored by Lipopharma Therapeutics, Spain. This study will be conducted in different countries in Europe and Israel.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/1195
Date of REC Opinion
18 Oct 2019
REC opinion
Further Information Favourable Opinion