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Clinical Trial Summary

The purpose of the clinical trial is to identify the maximum tolerated dose of SEL24/MEN1703 and to further investigate its safety profile in patients with Acute Myeloid Leukemia.


Clinical Trial Description

Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated dose of SEL24/MEN1703 in patients with Acute Myeloid Leukemia. The clinical trial will investigate the safety profile and anti-leukemic activity of SEL24/MEN1703 in patients with Acute Myeloid Leukemia and that have no standard therapeutic options available. The clinical trial encompasses two parts: - Part 1, ascending dose levels: the main purpose of this part of the clinical trial is to determine the highest dose of SEL24/MEN1703 considered to be well tolerated. - Part 2, expansion cohort: the main purpose of this part of the clinical trial is to assess the safety and anti-leukemia activity of SEL24/MEN1703 given at the highest tolerated dose in patient with relapsed/refractory Acute Myeloid Leukemia. Patients participating to the clinical trial will take the study drug as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03008187
Study type Interventional
Source Menarini Group
Contact Simone Baldini, MD
Phone +39 345 922 0957
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date March 10, 2017
Completion date October 2021

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