The purpose of the clinical trial is to identify the maximum tolerated dose of MEN1703
and to further investigate its safety profile in participants with acute myeloid leukemia
(AML).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03008187.
Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum
tolerated dose of MEN1703 in participants with acute myeloid leukemia.
The clinical trial will investigate the safety profile and anti-leukemic activity of
MEN1703 in participants with AML and that have no standard therapeutic options available.
The clinical trial encompasses 2 parts:
- Part 1: Ascending dose levels - the main purpose of this part of the clinical trial
is to determine the highest dose of 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 MEN1703 given at the highest
tolerated dose in participant with relapsed/refractory acute myeloid leukemia,
either all comers as well as harboring isocitrate dehydrogenase (IDH1/IDH2)
mutations.
Participants 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.
Lead OrganizationMenarini Group
