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

22. august 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

124

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Lexicon Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Lexicon Investigational Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Lexicon Investigational Site
  • Belgia
      • Edegem, Belgia, B-2650
        • Lexicon Investigational Site
      • Ghent, Belgia, 9000
        • Lexicon Investigational Site
      • Yvoir, Belgia, 5530
        • Lexicon Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
        • Lexicon Investgational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B0J1N0
        • Lexicon Investigational Site
  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36604
        • Lexicon Investigational Site
    • California
      • Stanford, California, Forente stater, 94305
        • Lexicon Investigational Site
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • Lexicon Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536
        • Lexicon Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Lexicon Investigational Site
    • New York
      • New York, New York, Forente stater, 10029
        • Lexicon Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Lexicon Investigational Site
  • Frankrike
      • Lille, Frankrike, 59037
        • Lexicon Investigational Site
      • Lyon, Frankrike, 69437
        • Lexicon Investigational Site
      • Villejuif, Frankrike, 94805
        • Lexicon Investigational Site
  • Israel
      • Jerusalem, Israel, 91120
        • Lexicon Investigational Site
  • Italia
      • Milano, Italia, 20089
        • Lexicon Investigational Site
      • Milano, Italia, 20141
        • Lexicon Investigational Site
      • Pisa, Italia, 56124
        • Lexicon Investigational Site
      • Torino, Italia, 10043
        • Lexicon Investigational Site
  • Nederland
      • Amsterdam, Nederland, 1105AZ
        • Lexicon Investigational Site
      • Noord Holland, Nederland, 1066CX
        • Lexicon Investigational Site
      • Noord-Brahant, Nederland, 5631BM
        • Lexicon Investigational Site
  • Spania
      • Barcelona, Spania, 08035
        • Lexicon Investigational Site
      • Madrid, Spania, 28034
        • Lexicon Investigational Site
      • Seville, Spania, 41013
        • Lexicon Investigational Site
  • Storbritannia
      • Coventry, Storbritannia, CV22DX
        • Lexicon Investigational Site
      • Glasgow, Storbritannia, G120YN
        • Lexicon Investigational Site
      • London, Storbritannia, NW32QG
        • Lexicon Investigational Site
      • London, Storbritannia, SE59RS
        • Lexicon Investigational Site
      • London, Storbritannia, W120HS
        • Lexicon Investigational Site
      • Manchester, Storbritannia, M204BX
        • Lexicon Investigational Site
      • Newcastle-Upon-Tyne, Storbritannia, NE14LP
        • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 250 mg Telotristat Etiprate
One telotristat etiprate (250 mg) tablet administered three times daily.
Legemiddel: Telotristat etiprate
Telotristat etiprate tablet (250 mg)
Andre navn:
  • LX1606
Eksperimentell: 500 mg Telotristat Etiprate
Two telotristat etiprate (250 mg) tablets administered three times daily.
Legemiddel: Telotristat etiprate
Telotristat etiprate tablet (250 mg)
Andre navn:
  • LX1606

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Lexicon Pharmaceuticals

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. januar 2014

Primær fullføring (Faktiske)

12. september 2018

Studiet fullført (Faktiske)

12. september 2018

Datoer for studieregistrering

Først innsendt

31. desember 2013

Først innsendt som oppfylte QC-kriteriene

31. desember 2013

Først lagt ut (Anslag)

1. januar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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