Acute Myeloid Leukemia Clinical Trial
SEL24/MEN1703 in Patients With Acute Myeloid Leukemia
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.
Full 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, either all comers as well as harboring IDH1/IDH2 mutations.
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.
Eligibility Criteria
Inclusion Criteria:
patients with diagnosis of Acute Myeloid Leukemia, all comers (completed) and bearing IDH1 or IDH2 mutation (open for recruitment)
Patient has no standard therapeutic options available and has either Relapsed AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy or Primary refractory AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy
Exclusion Criteria:
anti-cancer treatments (including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy or investigational drugs) received within 14 days or 5 half-lives for targeted therapies (whichever is shorter) before first dose of study drug (to be supplemented)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 7 Locations for this study
Atlanta Georgia, 30342, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Meldola , , Italy
Milano , , Italy
Monza , , Italy
Warsaw , , Poland
Åódź , , Poland
Badalona , , Spain
Madrid , , Spain
Valencia , , Spain
How clear is this clinincal trial information?