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MIN-001-1203: A Phase 1/2A Dose Escalation Study of 2-hydroxyoleic acid (2-OHOA) in Adult Patients with Advanced Solid Tumours including Malignant Glioma

 

This trial is an open label, non-randomized study in patients with advanced solid tumours including malignant glioma and consists of two phases 1) a dose-escalation phase following a standard “3+3” design to establish dose-limiting toxicity (DLT) and a safe dose of 2-OHOA and 2) an expansion phase with two expanded safety cohorts (approximately 10 of whom have malignant glioma and approximately 10 of whom have other advanced solid tumours that are suitable for biopsy) treated at the maximum tolerated dose (MTD). MIN-001-1203 trial has been conducted in leading investigational sites in London, Newcastle, Barcelona, San Sebastian and Bilbao.

 

Recruitment and treatment of patients in MIN-001-1203 study have been completed. A total of 54 patients have been treated, of which 46 are evaluable for safety assessment. 32 patients were recruited in 7 cohorts in the Dose-Escalation Phase and 22 patients in two safety expansion cohorts in the expanded phase. Results of the study are currently being evaluated and have confirmed an excellent safety profile, while relevant clinical activity (by RANO / RECIST v1.1) has been reported in several cases, including patients with recurrent malignant glioma.

For more information, please visit clinicaltrials.gov

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Financiado por el Ministerio de Economía y Competitividad. Plan Nacional de Investigación Científica, Desarrollo e Innovación Tecnológica 2008-2011. Subprograma INNCORPORA 2011 (INC-TU-2011-1007)

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