- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04034745
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
29 december 2020 uppdaterad av: Andrew Hendifar, MD
IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
This single arm study will evaluate whether Xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (NET) patients with a history of carcinoid syndrome.
Studieöversikt
Status
Indragen
Intervention / Behandling
Detaljerad beskrivning
The purpose of this study is to examine the mechanisms of weight gain associated with the drug telotristat ethyl (Xermelo) among patients with a neuroendocrine tumor (NET) with history of carcinoid syndrome.
We want to know if taking Xermelo affects patients' lean body mass, quality of life, dietary intake, and physical and cognitive functioning during treatment.
A better understanding of the mechanisms of weight gain from Xermelo may allow us to determine whether this drug may be beneficial for treating carcinoid syndrome, cachexia, or weight loss seen in other diseases.
Studietyp
Observationell
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients will be recruited from Cedars-Sinai Medical Center
Beskrivning
Inclusion Criteria:
- Age ≥ 18 years.
- Histopathologically confirmed diagnosis of a metastatic NET.
- Documented history of carcinoid syndrome.
- Currently receiving treatment with long-acting SSAs with a plan to initiate therapy with telotristat-ethyl as per standard of care.
- ECOG performance status 0-1 and/or Karnofsky >60%.
- Greater than or equal to 3 month life expectancy.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
- Patients experiencing more than 12 watery BMs per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection.
- History of short bowel syndrome.
- Clinically important baseline elevation in liver function tests.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Malignant ascites requiring paracenteses.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Bowel obstruction, partial, or total.
- Pregnancy
- Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment, other than diarrhea
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Standard of Care telotristat ethyl (Xermelo) Treatment
Treatment of telotristat ethyl (Xermelo) with DXA scans and bionutritional assessments (24-hour food recall and taste/smell alteration) conducted 3x during telotristat ethyl treatment.
|
250 mg tablets of Xermelo (telotristat ethyl) is administered orally 3x daily in combination with somatostatin analogs (SSAs) for approximately 84 days as per standard of care
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
Tidsram: From baseline to 13 weeks after treatment
|
From baseline to 13 weeks after treatment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mean change in patient reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from baseline up to 3 years post treatment.
Tidsram: From baseline to 3 years post treatment
|
The summary score (SS) is a mean of 13 QLQ-C30 subscale scores, ranging from 0 to 100, with a higher SS rating reflecting a better health status.
|
From baseline to 3 years post treatment
|
Mean change in patient reported outcomes using the Montreal Cognitive Assessment (MOCA) test from baseline up to 3 years post treatment.
Tidsram: From baseline to 3 years post treatment
|
MOCA scores range between 0 and 30, with higher scores indicating higher cognitive function.
|
From baseline to 3 years post treatment
|
Mean change in patient reported outcomes using a stool survey measured from baseline and after 13 weeks of treatment.
Tidsram: From baseline to 13 weeks post-treatment.
|
The stool survey is a non-validated descriptive measure of gastrointestinal symptoms by taking the mean score on a scale of 0 - 10, where 0 indicates no symptoms and higher scores denote a worsening of symptoms.
|
From baseline to 13 weeks post-treatment.
|
Mean change in calories consumed using a 24-hour food diary from baseline and after 13 weeks of treatment.
Tidsram: From baseline to 13 weeks post-treatment
|
From baseline to 13 weeks post-treatment
|
|
Mean change in daily activity levels (steps) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Tidsram: From baseline to 13 weeks post-treatment
|
From baseline to 13 weeks post-treatment
|
|
Mean change in daily activity levels [stairs (floors) climbed] as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Tidsram: From baseline to 13 weeks post-treatment
|
From baseline to 13 weeks post-treatment
|
|
Mean change in daily activity levels (sleep duration) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Tidsram: From baseline to 13 weeks post-treatment
|
From baseline to 13 weeks post-treatment
|
|
Mean change in daily activity levels (heart rate) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Tidsram: From baseline to 13 weeks post-treatment
|
From baseline to 13 weeks post-treatment
|
|
Mean change in daily activity levels (active minutes) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Tidsram: From baseline to 13 weeks post-treatment
|
From baseline to 13 weeks post-treatment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 oktober 2020
Primärt slutförande (Förväntat)
1 november 2022
Avslutad studie (Förväntat)
1 november 2023
Studieregistreringsdatum
Först inskickad
29 juni 2019
Först inskickad som uppfyllde QC-kriterierna
25 juli 2019
Första postat (Faktisk)
26 juli 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 december 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 december 2020
Senast verifierad
1 december 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIT2018-26 -Hendifar-NETCx
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Bukspottskörtelcancer
-
Tianjin Medical University Cancer Institute and...Har inte rekryterat ännuPDAC - Pancreatic Ductal Adenocarcinoma
-
Sun Yat-sen UniversityRekryteringPDAC - Pancreatic Ductal AdenocarcinomaKina
-
Azienda Ospedaliera Universitaria Integrata VeronaRekryteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Azienda Ospedaliera Universitaria Integrata VeronaRekryteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Cedars-Sinai Medical CenterRekryteringPDAC - Pancreatic Ductal AdenocarcinomaFörenta staterna
-
Radboud University Medical CenterDutch Cancer SocietyRekryteringPDAC - Pancreatic Ductal AdenocarcinomaNederländerna
-
Imperial College LondonThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS... och andra samarbetspartnersRekryteringBukspottskörtelcancer | PDAC - Pancreatic Ductal AdenocarcinomaStorbritannien
-
Chinese PLA General HospitalRekryteringPankreatiska neoplasmer | Bukspottskörtelcancer | Bukspottkörtelcancer | PDAC - Pancreatic Ductal AdenocarcinomaKina
-
Andrei IagaruInte längre tillgängligKarcinoida tumörer | Islet Cell (Pancreatic NET) | Andra neuroendokrina tumörerFörenta staterna
-
Mayo ClinicRekryteringBukspottskörtelcancer | Duktalt adenokarcinom i bukspottkörteln | PDAC | PDAC - Pancreatic Ductal AdenocarcinomaFörenta staterna
Kliniska prövningar på telotristat ethyl
-
Altavant Sciences GmbHParexel; Altavant Sciences, Inc.Avslutad
-
Altavant Sciences GmbHPPDAvslutad
-
M.D. Anderson Cancer CenterTerSera Therapeutics LLCRekryteringLokalt avancerad neuroendokrin neoplasma | Metastaserande neuroendokrin neoplasmaFörenta staterna
-
Lexicon PharmaceuticalsAvslutadNedsatt leverfunktionFörenta staterna
-
Nizam's Institute of Medical Sciences University...AvslutadStrokepatienter som uppträder inom 24 timmar efter symtomdebut
-
University of ChicagoIndragen
-
European Organisation for Research and Treatment...IpsenIndragen
-
Canadian Medical and Surgical Knowledge Translation...Unity Health Toronto; Western University, Canada; HLS Therapeutics, IncAvslutadHjärt-kärlsjukdomar | Diabetes mellitus, typ 2 | Kardiovaskulär riskfaktor | Höga triglyceriderKanada
-
University of PennsylvaniaAmarin Pharma Inc.AvslutadDyslipidemier | Lipidstörning | Höga triglyceriderFörenta staterna
-
RDC Clinical Pty LtdAvslutadOptimal gastrointestinal absorption av Omega-3Australien