Trial intelligence / Profile preview

LAM561 in advanced solid tumours and malignant glioma

NCT01792310Phase 2

Key facts

Status: Completed
Start: May 2013
Primary completion: Sep 2016
Countries: 2
Sponsor: Laminar Pharma
Modality: Small Molecules

Drugs: 2-hydroxyoleic acid
Conditions: solid tumormalignant glioma

Overview

Phase 2, open-label trial of 2-hydroxyoleic acid in solid tumor and malignant glioma (9 cohorts), sponsored by Laminar Pharma. Primary endpoint: Number of patients with adverse events. Started May 2013; status: completed.

Design

9 arms

Study design: Non-randomizedOpen-label

Dose Cohort 1
LAM561 250 mg twice daily
Dose Cohort 2
LAM561 500 mg twice daily
Dose Cohort 3
LAM561 1g twice daily
Dose Cohort 4
LAM561 2g twice daily
Dose Cohort 5
LAM561 4g twice daily
Dose Cohort 6
LAM561 4g three times daily

3 more in the full profile.

Who it enrols

Adult patients with advanced solid tumours or malignant glioma refractory to standard therapy, with ECOG 0-2 and life expectancy >12 weeks.

Endpoints

Primary

Number of patients with adverse eventsFrom first dose until 30 days after last dose

Secondary

Concentration of LAM561 in blood measured by LC-MS/MS21 days
Concentration of biomarkers in blood or tumour tissueevery 9 cycles
Concentration of micro RNA in bloodevery 9 cycles
Radiological disease progressionEvery 6 weeks
Clinical disease progressionUntil discontinuation

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