- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03444649
Epacadostat, Idarubicin and Cytarabine (EIC) in AML (EIC)
Epacadostat With Idarubicin and Cytarabine (EIC) for First-line Treatment of AML Patients Fit for Intensive Chemotherapy; a Phase I Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
-
Berne, Schweiz, 3010
- Departement of Medical Oncology, University Hospital Berne
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
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.
- 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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Dosis finding
Epacadostat is given for 2 cycles of 28 days at a dose according to the titration design together with Standard chemotherapy (Idarubicin and Cytarabine)
|
Epacadostat orally two times daily (BID) for two cycles (28 days each) in combination with standard induction chemotherapy (Idarubicin and Cytarabine)
Standard chemotherapy d1-d3 cycle 1
Standard chemotherapy d1-d7 cycle 1 and 2
Standard chemotherapy d1-3 cycle 2
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Phase 1: Dose finding
Tidsramme: 30 days
|
To determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat
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30 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rate af morfologisk fuldstændig remission (CR)
Tidsramme: 60 dage
|
Knoglemarvssprængninger < 5 %; fravær af sprængninger med Auer-stænger; fravær af ekstramedullær sygdom; absolut neutrofiltal > 1,0G/L (1000/μL); blodpladetal > 100 x G/L (100.000/μL);
uafhængighed af transfusioner af røde blodlegemer.
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60 dage
|
Samlet overlevelse
Tidsramme: 12 måneder
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Antal patienter i live efter 12 måneder
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12 måneder
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Adverse events
Tidsramme: 90 days
|
Number of patients experiencing toxicity (Adverse Events)
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90 days
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Cytarabin
- Daunorubicin
- Idarubicin
Andre undersøgelses-id-numre
- EIC-trial
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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