Epacadostat, Idarubicin and Cytarabine (EIC) in AML — EIC  

AML Clinical Trial

Official title: Epacadostat With Idarubicin and Cytarabine (EIC) for First-line Treatment of AML Patients Fit for Intensive Chemotherapy; a Phase I Study

Status Withdrawn

Clinical Trial Summary

This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the anthracycline/cytarabine combination as first-line induction treatment in AML patients fit for intensive treatment

Clinical Trial Description

Background and Rationale:

Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1). Indoleamine 2,3- dioxygenase 1 (IDO1) is a 403 amino acid cytosolic haem enzyme encoded by the INDO gene on human chromosome 8p22. IDO1 is responsible for the catabolism of the essential amino acid tryptophan (trp) to kynurenine (kyn) within immune cells and a subset of tumor cells resulting in inhibition of antitumor cell-mediated immune responses. Increased IDO activity correlates with lower CR rates and shorter OS in AML.

Objective:

The primary objective is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the anthracycline/cytarabine combination as first-line induction treatment in AML patients fit for intensive Treatment.

Study Duration:

Phase I part will last from 3 to 18 months (permitting the enrolment of minimum of 3 and a maximum of 18 patients). ;

Related Conditions & MeSH terms

• AML

• NCT number: NCT03444649
• Study type: Interventional
• Source: University Hospital Inselspital, Berne
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 2018
• Completion date: October 2019