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Epacadostat, Idarubicin and Cytarabine (EIC) in AML

NCT03444649 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-09-11

No results posted yet for this study

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

Interventions

DRUG

Epacadostat

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

DRUG

Idarubicin

Standard chemotherapy d1-d3 cycle 1

DRUG

Cytarabine

Standard chemotherapy d1-d7 cycle 1 and 2

DRUG

Daunorubicin

Standard chemotherapy d1-3 cycle 2

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-08-31
Completion
2019-10-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03444649 on ClinicalTrials.gov