Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies

16. december 2020 opdateret af: Novartis Pharmaceuticals

A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies

This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

175

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Australien
    • Victoria
      • Parkville, Victoria, Australien, 3002
        • Novartis Investigative Site
      • Prahran, Victoria, Australien, 3181
        • Novartis Investigative Site
  • Forenede Stater
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana Farber Cancer Institute
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • MD Anderson Cancer Center/University of Texas
  • Tyskland
      • Frankfurt/M, Tyskland, 60590
        • Novartis Investigative Site
      • Mainz, Tyskland, 55131
        • 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:

  • Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
  • World Health Organization (WHO) performance status ≤ 2
  • Patients who met protocol-specified hematologic and non-hematologic laboratory values
  • Patients with adequate liver and renal function

Exclusion criteria:

  • Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
  • Peripheral neuropathy ≥ CTCAE grade 2
  • Unresolved diarrhea ≥ CTCAE grade 2
  • Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
  • Female patients who were pregnant or breast feeding
  • Patients who were unwilling to use an effective method of birth control
  • Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
  • Patients with another primary malignancy that required active intervention or were clinically significant

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1, Group X
Medicin: LBH589
Eksperimentel: Arm 1, Group Y
Medicin: LBH589
Eksperimentel: Arm 2, Group X
Medicin: LBH589
Eksperimentel: Arm 2, Group Y
Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
Medicin: LBH589

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants DLT in Arm 1 in Dose Escalation Phase
Tidsramme: Cycle 1 (28-day treatment cycle)
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Cycle 1 (28-day treatment cycle)
Number of Participants DLT in Arm 2 in Dose Escalation Phase
Tidsramme: Cycle 1 (28-day treamtent cycle)

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly).

A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Cycle 1 (28-day treamtent cycle)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Tidsramme: 3.5 years
Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
3.5 years
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Tidsramme: 1.2 years
Stage 2 did not open for enrollment.
1.2 years
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Tidsramme: 3.5 years
Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.
3.5 years
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Tidsramme: 3.5 years
Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
3.5 years
Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
Tidsramme: Day 1
Day 1
Half Life of Panobinostat After the First Dose in Arms 1 and 2
Tidsramme: Day 1
Day 1
Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
Tidsramme: Day 15
From day 15 by dose with schedule: MWF every week
Day 15
Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
Tidsramme: Day 15
Day 15
Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
Tidsramme: Day 15/day 1
MWF Every week schedule n = number of subjects with non-missing values.
Day 15/day 1
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Tidsramme: Days 1, 5, 8, 10, 15
Reporting the number of patients with a reading at the timepoint in the dose group.
Days 1, 5, 8, 10, 15
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
Tidsramme: Days 5, 8, end of study (up to 3.5 years)
Days 5, 8, end of study (up to 3.5 years)
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Tidsramme: Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)
Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Tidsramme: Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)
Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)
Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
Tidsramme: Post dose to pre-dose (up to 3.5 years)
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))
Post dose to pre-dose (up to 3.5 years)
Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
Tidsramme: Post dose to pre-dose (up to 3.5 years)
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))
Post dose to pre-dose (up to 3.5 years)

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.

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 (Faktiske)

1. marts 2003

Primær færdiggørelse (Faktiske)

3. december 2009

Studieafslutning (Faktiske)

3. december 2009

Datoer for studieregistrering

Først indsendt

12. februar 2008

Først indsendt, der opfyldte QC-kriterier

21. februar 2008

Først opslået (Skøn)

22. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. december 2020

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLBH589B2102
  • 2005-003670-26

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 LBH589

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cote d'Ivoire

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner