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Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms (TELEPATH)

22. august 2019 opdateret af: Lexicon Pharmaceuticals

A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

124

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • St. Leonards, New South Wales, Australien, 2065
        • Lexicon Investigational Site
    • Queensland
      • Herston, Queensland, Australien, 4029
        • Lexicon Investigational Site
    • Victoria
      • East Melbourne, Victoria, Australien, 3002
        • Lexicon Investigational Site
  • Belgien
      • Edegem, Belgien, B-2650
        • Lexicon Investigational Site
      • Ghent, Belgien, 9000
        • Lexicon Investigational Site
      • Yvoir, Belgien, 5530
        • Lexicon Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
        • Lexicon Investgational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B0J1N0
        • Lexicon Investigational Site
  • Det Forenede Kongerige
      • Coventry, Det Forenede Kongerige, CV22DX
        • Lexicon Investigational Site
      • Glasgow, Det Forenede Kongerige, G120YN
        • Lexicon Investigational Site
      • London, Det Forenede Kongerige, NW32QG
        • Lexicon Investigational Site
      • London, Det Forenede Kongerige, SE59RS
        • Lexicon Investigational Site
      • London, Det Forenede Kongerige, W120HS
        • Lexicon Investigational Site
      • Manchester, Det Forenede Kongerige, M204BX
        • Lexicon Investigational Site
      • Newcastle-Upon-Tyne, Det Forenede Kongerige, NE14LP
        • Lexicon Investigational Site
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36604
        • Lexicon Investigational Site
    • California
      • Stanford, California, Forenede Stater, 94305
        • Lexicon Investigational Site
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Lexicon Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Lexicon Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Lexicon Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10029
        • Lexicon Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Lexicon Investigational Site
  • Frankrig
      • Lille, Frankrig, 59037
        • Lexicon Investigational Site
      • Lyon, Frankrig, 69437
        • Lexicon Investigational Site
      • Villejuif, Frankrig, 94805
        • Lexicon Investigational Site
  • Holland
      • Amsterdam, Holland, 1105AZ
        • Lexicon Investigational Site
      • Noord Holland, Holland, 1066CX
        • Lexicon Investigational Site
      • Noord-Brahant, Holland, 5631BM
        • Lexicon Investigational Site
  • Israel
      • Jerusalem, Israel, 91120
        • Lexicon Investigational Site
  • Italien
      • Milano, Italien, 20089
        • Lexicon Investigational Site
      • Milano, Italien, 20141
        • Lexicon Investigational Site
      • Pisa, Italien, 56124
        • Lexicon Investigational Site
      • Torino, Italien, 10043
        • Lexicon Investigational Site
  • Spanien
      • Barcelona, Spanien, 08035
        • Lexicon Investigational Site
      • Madrid, Spanien, 28034
        • Lexicon Investigational Site
      • Seville, Spanien, 41013
        • Lexicon Investigational Site
  • Sverige
      • Lund, Sverige, 22185
        • Lexicon Investigational Site
      • Uppsala, Sverige, 75185
        • Lexicon Investigational Site
  • Tyskland
      • Bad Berka, Tyskland, 99437
        • Lexicon Investigational Site
      • Berlin, Tyskland, 13353
        • Lexicon Investigational Site
      • Essen, Tyskland, 45147
        • Lexicon Investigational Site
      • Hamburg, Tyskland, 20246
        • Lexicon Investigational Site
      • Marburg, Tyskland, 35043
        • Lexicon Investigational 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:

  • Ongoing participation in a Phase 2 [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415)] or Phase 3 [LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] study
  • Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit.
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study
  • Positive pregnancy test
  • Presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination

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: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 250 mg Telotristat Etiprate
One telotristat etiprate (250 mg) tablet administered three times daily.
Medicin: Telotristat etiprate
Telotristat etiprate tablet (250 mg)
Andre navne:
  • LX1606
Eksperimentel: 500 mg Telotristat Etiprate
Two telotristat etiprate (250 mg) tablets administered three times daily.
Medicin: Telotristat etiprate
Telotristat etiprate tablet (250 mg)
Andre navne:
  • LX1606

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug.
First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit
Tidsramme: Baseline, Weeks 24, 48, 72 and 84
QLQ-C30 is a standardized 30-item scale to assess health-related quality of life composed of 5 functional scales (physical functioning [5 items], role functioning [2 items], emotional functioning [4 items], cognitive functioning [2 items], and social functioning [2 items]); 3 symptom scales (fatigue [3 items], nausea/vomiting [2 items], and pain [2 items]); a global health status (GHS) /quality of life (QOL) scale [2 items]; 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). 28 questions answered:1 (not at all) to 4 (very much) and 2 questions on overall health/QOL answered:1 (poor) to 7 (excellent). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).
Baseline, Weeks 24, 48, 72 and 84
Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
Tidsramme: Baseline, Weeks 24, 48, 72 and 84
GI.NET21 is a standardized 21-item scale composed of both multi-item scales and single-item measures that include 5 functional scales (gastrointestinal (GI) [5 items], endocrine [3 items], treatment-related [3 items], social functioning [3 items], and disease-related worries scale [DRWS] [3 items]) and 4 single items (muscle and bone pain symptom (BPS), sexual functioning, communication function (CF), body image and information about the disease). Each item is scored from 1 (not at all) to 4 (very much). All of the scales and single-item measures are transformed to a score of 0 to 100. For functioning scales higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).
Baseline, Weeks 24, 48, 72 and 84
Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
Tidsramme: Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Participants were asked to respond to the following question: "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort? The percentage of participants reporting adequate relief (answered Yes) were reported.
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
Tidsramme: Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Participants were asked the following question to assess global symptoms associated with carcinoid syndrome (CS) on an 11-point scale: "Rate the severity of your overall carcinoid symptoms over the past 7 days on a scale from 0 to 10, where 0=no symptoms and 10=worst symptoms ever experienced. A negative change from baseline indicated improvement.
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84

Samarbejdspartnere og efterforskere

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

Sponsor

Lexicon Pharmaceuticals

Efterforskere

  • Studieleder: Pablo LaPuerta, MD, Lexicon Pharmaceuticals, Inc.

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

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)

14. januar 2014

Primær færdiggørelse (Faktiske)

12. september 2018

Studieafslutning (Faktiske)

12. september 2018

Datoer for studieregistrering

Først indsendt

31. december 2013

Først indsendt, der opfyldte QC-kriterier

31. december 2013

Først opslået (Skøn)

1. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LX1606.1-302-CS
  • LX1606.302 (Anden identifikator: Lexicon Pharmaceuticals, Inc.)
  • 2013-002596-18 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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 Carcinoid syndrom

Kliniske forsøg med Telotristat etiprate

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malaysia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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