A Phase 1/2A Dose Escalation Study of 2-hydroxyoleic Acid (2-OHOA; Minerval®) in Adult Patients With Advanced Solid Tumours Including Malignant Glioma
This is an open label, non-randomized study in patients with advanced solid tumours
including malignant glioma. The study will be performed in two phases - a dose escalation
phase following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a safe
dose of 2-OHOA followed by 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). If the MTD is well
tolerated in the expanded safety cohorts, that dose becomes the recommended phase 2 dose
(RP2D). During each dose cohort, at least one week must elapse between the first and
subsequent patients receiving treatment with 2-OHOA. Up to five dose cohorts are
anticipated.
Patients may receive palliative localized radiotherapy, if needed (however, this lesion
cannot be a target lesion for evaluation of the treatment response).
Safety, pharmacokinetics (PK), pharmacodynamics and efficacy will be evaluated during the
study at pre-defined timepoints
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with adverse events
All adverse events will be recorded including clinically significant physical examinations and vital signs, laboratory safety tests and 12-lead electrocardiograms
From the first dose of study drug until 30 days after the last dose of study drug
Yes
Professor Johann de Bono, MB ChB FRCP MSc PhD
Study Chair
The Institute of Cancer Research, 15 Cotswold Road, Belmont, Sutton, Surrey, United Kingdom SM2 5NG
United Kingdom: Medicines and Healthcare Products Regulatory Agency
MIN-001-1203
NCT01792310
May 2013
November 2014
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