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Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

26. februar 2019 opdateret af: Lexicon Pharmaceuticals

A Phase 2, Open-Label, Multi-Center, Serial Ascending-Dose, Dose-Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects With Symptomatic Carcinoid Syndrome

The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
      • Basingstoke, Det Forenede Kongerige
        • Lexicon Investigational Site
      • Cambridge, Det Forenede Kongerige
        • Lexicon Investigational Site
      • London, Det Forenede Kongerige
        • Lexicon Investigational Site
      • Manchester, Det Forenede Kongerige
        • Lexicon Investigational Site
  • Tyskland
      • Bad Berka, Tyskland
        • Lexicon Investigational Site
      • Berlin, Tyskland
        • Lexicon Investigational Site
      • Halle, Tyskland
        • Lexicon Investigational Site
      • Lubeck, Tyskland
        • Lexicon Investigational Site
      • Marburg, Tyskland
        • Lexicon Investigational Site
      • Munich, Tyskland
        • 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:

  • Males and females, aged 18 and older
  • Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
  • Symptomatic carcinoid syndrome (≥4 bowel movements per day)
  • Ability to provide written informed consent

Exclusion Criteria:

  • ≥ 12 high-volume, watery bowel movements per day
  • Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
  • Karnofsky status ≤70% - unable to care for self
  • Surgery within 60 days prior to screening
  • A history of short bowel syndrome
  • Life expectancy < 12 months
  • History of substance or alcohol abuse within 2 years prior to screening
  • Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening

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: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Telotristat etiprate - Core Phase
Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period.
Medicin: Telotristat etiprate
Telotristat etiprate capsules orally three times daily.
Andre navne:
  • LX1606 Hippurat
Eksperimentel: Telotristat etiprate - Extension Period
Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.
Medicin: Telotristat etiprate
Telotristat etiprate capsules orally three times daily.
Andre navne:
  • LX1606 Hippurat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase
Tidsramme: Baseline up to Week 12 in the Core Phase
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1.
Baseline up to Week 12 in the Core Phase
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period
Tidsramme: Up to 124 Weeks in the Extension Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1.
Up to 124 Weeks in the Extension Period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Number of Bowel Movements (BMs)
Tidsramme: Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Participants recorded the number of bowel movements in a daily diary. The change from baseline value was calculated as the difference between mean numbers of BMs of the post-baseline interval (Weeks 9 to 12) and baseline. A negative change from baseline indicates improvement. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Change From Baseline in Stool Form/Consistency
Tidsramme: Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Participants assessed stool form/consistency in a daily diary using a 6-point scale (0-none, 1-hard, 2-firm, 3-soft, 4-loose, 5-watery). The change from the baseline value was calculated as the difference between a mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicates the best score and 5 indicates the worst score. A negative change from baseline indicates improvement. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate
Tidsramme: Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Participants assessed the urgency to defecate using a daily diary response to the following question, "Have you felt or experienced a sense of urgency to pass stool today?". The change from the baseline value was calculated as the difference between the mean score (percentage of days) of the post-baseline interval (Weeks 9 to 12) and baseline. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Change From Baseline in Sensation/Severity of Nausea Using 100 mm Visual Analog Scale (VAS)
Tidsramme: Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Sensation/severity of nausea was measured using a 100 mm VAS. Participants rated their perception of the sensation/severity of nausea experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No vomiting and 100 = vomiting. The change from the baseline value was calculated as the difference between the mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicates the best score, 100 indicates the worst score. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome
Tidsramme: Core Phase: Weeks 9-12; Extension Period: Week 24
Participants assessed their symptoms using a weekly subjective response 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 values for improvement in global assessment of symptoms associated with carcinoid syndrome in the Core Phase were averaged from Weeks 9 to 12.
Core Phase: Weeks 9-12; Extension Period: Week 24
Change From Baseline in Daily Severity of Abdominal Pain or Discomfort Using 100 mm Visual Analog Scale (VAS)
Tidsramme: Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
The severity of abdominal pain was measured using a 100 mm VAS. Participants rated their perception of the sensation/severity of abdominal pain or experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No vomiting and 100 = vomiting. The change from the baseline value was calculated as the difference between the mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicate the best score, 100 indicates the worst score. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Change From Baseline in Daily Number of Cutaneous Flushing Episodes
Tidsramme: Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Participants recorded the number of daily cutaneous flushing episodes experienced in the daily diary. The change from baseline value was calculated as the difference between the mean numbers of cutaneous flushing episodes of the post-baseline interval (Weeks 9 to 12) and baseline. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Number of Participants Achieving Clinically Meaningful Symptom Reduction in the Core Phase
Tidsramme: Baseline to Week 12
Clinically meaningful symptom reduction was defined as either: a) an average of < 4 bowel movements per day over 15 consecutive days, b) a 50% reduction from baseline in the number of bowel movements, c) a positive response to the question regarding adequate relief, or d) a 50% reduction from baseline in the number of daily flushing episodes.
Baseline to Week 12
Change From Baseline in Urinary 5-Hydroxyindoleacetic Acid (HIAA) Levels
Tidsramme: Core Phase: Baseline to Week 12; Extension Period: Baseline to Weeks 20-21
Urinary 5-HIAA (u5-HIAA) is a standard test used in clinical practice to assess the neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. The change from baseline value for the Extension Period was calculated as the difference between mean change in 5-HIAA of the post-baseline interval (Weeks 20 to 21) and baseline. A negative change from baseline indicates improvement. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.
Core Phase: Baseline to Week 12; Extension Period: Baseline to Weeks 20-21

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)

15. juni 2010

Primær færdiggørelse (Faktiske)

12. februar 2014

Studieafslutning (Faktiske)

12. februar 2014

Datoer for studieregistrering

Først indsendt

12. april 2010

Først indsendt, der opfyldte QC-kriterier

13. april 2010

Først opslået (Skøn)

15. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LX1606.1-203-CS
  • LX1606.203, LX1032 (Anden identifikator: Lexicon Pharmaceuticals, Inc.)
  • 2009-016973-13 (EudraCT nummer)

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 Carcinoid syndrom

Kliniske forsøg med Telotristat etiprate

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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CROs in Argentina

Betingelser

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