Epacadostat, Idarubicin and Cytarabine (EIC) in AML

NCT03444649 | Withdrawn Phase 1

• 1 other identifier: EIC-trial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

AML

Keywords

AML; Epacadostat; Idarubicin; Cytarabine

Outcome Measures

Primary Outcomes (1)

• Phase 1: Dose finding

  To determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat

  30 days

Secondary Outcomes (3)

• Rate of morphologic complete remission (CR)

  60 days

• Adverse events

  90 days

• Overall survival

  12 months

Study Arms (1)

Dosis finding

EXPERIMENTAL

Epacadostat is given for 2 cycles of 28 days at a dose according to the titration design together with Standard chemotherapy (Idarubicin and Cytarabine)

Drug: Epacadostat; Drug: Idarubicin; Drug: Cytarabine; Drug: Daunorubicin

Interventions

Epacadostat DRUG

Epacadostat orally two times daily (BID) for two cycles (28 days each) in combination with standard induction chemotherapy (Idarubicin and Cytarabine)

Dosis finding

Idarubicin DRUG

Standard chemotherapy d1-d3 cycle 1

Dosis finding

Cytarabine DRUG

Standard chemotherapy d1-d7 cycle 1 and 2

Dosis finding

Daunorubicin DRUG

Standard chemotherapy d1-3 cycle 2

Dosis finding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AML (according to the 2016 World Health Organization (WHO) classification definition of ≥ 20% blasts; Arber et al, 2016) suitable for intensive treatment (including stem cell transplantation) with a curative intent.
• Patients must be aged \> 18 years, and must have given voluntary written informed consent.
• Women of childbearing potential having a negative serum pregnancy test at screening or at least within 48 hours before start with epacadostat, and willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 6 months after the last study drug administration
• Men willing to use an effective contraceptive method (eg, condom, vasectomy) during the study and for at least 6 months after the last study drug administration.

You may not qualify if:

• Prior or concurrent malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the subject has been disease-free for more than 6 months.
• Any previous AML or MDS chemotherapy (with the exception of hydroxyurea/Litalir® for leukocyte control which should be discontinued by the first day of induction chemotherapy
• Treatment with any investigational product within 4 weeks before the first administration of epacadostat (INCB024360)
• Abnormal organ function if not caused by the underlying disease as considered by the treating physician
• Use of immune-suppressive agents for the past 4 weeks before the first administration of epacadostat (INCB024360). For regular use of systemic corticosteroids, subjects may only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days before the first administration of epacadostat (INCB024360)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Departement of Medical Oncology, University Hospital Berne

Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

epacadostat; Idarubicin; Cytarabine; Daunorubicin

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 23, 2018
• Study Start: September 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

CH (1)