ClinicalTrials.gg
Sign In
WithdrawnNCT03491579ECCUpdated Sep 11, 2018

Epacadostat, Cladribine and Cytarabine (ECC) in AML

A Phase 1 interventional study of Epacadostat and Cladribine in AML and Relapse, sponsored by Insel Gruppe AG, University Hospital Bern. Withdrawn at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-11.

Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 1, Interventional, and Treatment

Why this study was withdrawn
IMP will not be further developed
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine chemotherapy in relapsed / refractory AML patients fit for intensive treatment

Read the detailed 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 cladribine/cytarabine chemotherapy in relapsed / refractory 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 24 patients).

02

Conditions studied

  • AML
  • Relapse

Browse trials for

Keywords

  • AML
  • Epacadostat
  • Cladribine
  • Cytarabine
03

In context

Recurrence

4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.

Browse Recurrence studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 737 studies on the registry; 178 are open to participants now.

Browse Insel Gruppe AG, University Hospital Bern studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Relapsed/refractory AML (according to the 2016 World Health Organization (WHO) classification definition of ≥ 20% blasts; Arber et al, 2016) after at least one line of treatment and suitable for intensive treatment (including stem cell transplantation) without severe concurrent infections.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • APL (acute promyelocytic leukemia) or AML type M3, are excluded from the trial
  • 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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Dosis finding

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

    Drug: Epacadostat · Drug: Cladribine · Drug: Cytarabine

Interventions

  • DrugEpacadostat

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

  • DrugCladribine

    Standard chemotherapy

  • DrugCytarabine

    Standard chemotherapy

06

What researchers measure

Primary outcomes

  1. Dose finding

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

    Time frame: 30 days

Secondary outcomes

  1. Rate of morphologic complete remission (CR)

    Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0G/L (1000/μL); platelet count \> 100 x G/L (100.000/μL); independence of red cell transfusions.

    Time frame: 60 days

  2. Adverse events

    Number of patients experiencing toxicity (Adverse Events)

    Time frame: 100 days

  3. Overall survival

    Number of patients alive after 12 months

    Time frame: 12 months

07

Study locations

1 site
  • Departement of Medical Oncology, University Hospital Berne
    Bern, 3010, Switzerland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2018; primary completion for Sep 2019, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2018
First posted
Apr 9, 2018
StartEst.
Dec 2018
Primary completionEst.
Sep 2019
CompletionEst.
Oct 2019
Last update
Sep 11, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03491579
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Apr 9, 2018
Start date
Dec 2018 (estimated)
Primary completion
Sep 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Sep 11, 2018

Study contacts

Thomas Pabst, Prof
study chair · Departement of Medical Oncology, University Hospital Berne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Epacadostat · Cladribine · Cytarabine

Other studies in this condition

Recurrence →

Other studies from this sponsor

Insel Gruppe AG, University Hospital Bern →

Start the discussion