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Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

16. december 2020 opdateret af: Novartis Pharmaceuticals

A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese patients with relapsed and/or refractory multiple myeloma for which no standard effective treatment options exist.

The study consists of a dose escalation part to estimate the maximum tolerated dose and/or the recommended dose for expansion and a dose expansion part to further assess safety and preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the recommended dose for expansion.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
    • Aichi
      • Nagoya-city, Aichi, Japan, 467-8602
        • Novartis Investigative Site
    • Hyogo
      • Kobe-city, Hyogo, Japan, 650-0017
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 602-8566
        • Novartis Investigative Site
    • Okayama
      • Okayama-city, Okayama, Japan, 701-1192
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

-Confirmed diagnosis of relapsed and/or refractory MM for which no standard effective treatment options exist.

Exclusion Criteria:

-Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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: LGH447
LGH447, QD
Medicin: LGH447
LGH447, QD

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence rate of dose limiting toxicities
Tidsramme: 28 days
Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients
28 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients with adverse events as a measure of safety and tolerability of LGH447
Tidsramme: 28 days and till the end of the study, an average of 84 days
Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms
28 days and till the end of the study, an average of 84 days
Pharmacokinetics profile of LGH447 and its metabolites if appropriate
Tidsramme: Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1
PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days
Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1
Overall Response Rate
Tidsramme: Every 28 days till the end of the study, an average of 84 days
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Every 28 days till the end of the study, an average of 84 days
Disease control rate
Tidsramme: Every 28 days till the end of the study, an average of 84 days
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Every 28 days till the end of the study, an average of 84 days
Clinical benefit rate
Tidsramme: Every 28 days till the end of the study, an average of 84 days
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Every 28 days till the end of the study, an average of 84 days
Duration of Response
Tidsramme: Every 28 days till the end of the study, an average of 84 days, from the first documented onset of confirmed PR or better response to the date of documented disease progression/relapse or death due to multiple myeloma
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Every 28 days till the end of the study, an average of 84 days, from the first documented onset of confirmed PR or better response to the date of documented disease progression/relapse or death due to multiple myeloma
Progression Free Survival
Tidsramme: Every 28 days till the end of the study, an average of 84 days, from start of treatment to the date of event defined as the first documented disease progression/relapse, or death due to any cause
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Every 28 days till the end of the study, an average of 84 days, from start of treatment to the date of event defined as the first documented disease progression/relapse, or death due to any cause
Time to response
Tidsramme: Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2014

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

30. maj 2014

Først indsendt, der opfyldte QC-kriterier

9. juni 2014

Først opslået (Skøn)

11. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. december 2020

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLGH447X1101

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Myelomatose

Kliniske forsøg med LGH447

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Norway

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner