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.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511542-39-00

Acronym

MIN-003-1806

Enrollment

106

Registered

2024-03-15

Start date

2019-09-16

Completion date

Unknown

Last updated

2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed primary glioblastoma multiforme (ndGBM)

Brief summary

• PFS according to RANO criteria evaluated after at least 66 PFS events occur. Occurrence of disease progression to calculate PFS will be determined first by the investigator based on local evaluation of images and other clinical information. Progression will be confirmed by an adjudication/imaging committee. • Overall Survival evaluated after at least 90 OS events are observed.

Detailed description

• Changes in neurological function, based on Neurologic Assessment in Neuro-Oncology (NANO) criteria • To evaluate additional measures of efficacy including: o Time to Progression (TTP) (as assessed using RANO criteria) • HRQoL assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC-QLQ C30, version 3.0 and brain cancer specific QLQ-BN20. • Please refer to protocol for full list

Interventions

DRUGTemodal 100 mg hard capsules

DRUGTemodal 250 mg hard capsules

DRUGPlacebo

DRUG2-Hydroxyoleic acid sodium salt

DRUGTemodal 140 mg hard capsules

DRUGTemodal 5 mg hard capsules

DRUGTemodal 20 mg hard capsules

DRUGTemodal 180 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• PFS according to RANO criteria evaluated after at least 66 PFS events occur. Occurrence of disease progression to calculate PFS will be determined first by the investigator based on local evaluation of images and other clinical information. Progression will be confirmed by an adjudication/imaging committee. • Overall Survival evaluated after at least 90 OS events are observed.	—

Secondary

Measure	Time frame
• Changes in neurological function, based on Neurologic Assessment in Neuro-Oncology (NANO) criteria • To evaluate additional measures of efficacy including: o Time to Progression (TTP) (as assessed using RANO criteria) • HRQoL assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC-QLQ C30, version 3.0 and brain cancer specific QLQ-BN20. • Please refer to protocol for full list	—

Measure

Time frame

—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026