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SEL24 / MEN1703 in Patients With Acute Myeloid Leukemia

Trial Status: Active

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.

Inclusion Criteria

  • patients with diagnosis of Acute Myeloid Leukemia
  • 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)

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL

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.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Menarini Group

  • Primary ID CLI24-001
  • Secondary IDs NCI-2017-00611
  • Clinicaltrials.gov ID NCT03008187