Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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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.
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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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
Periodo de tiempo: From baseline to 13 weeks after treatment
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From baseline to 13 weeks after treatment
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: From baseline to 3 years post treatment
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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.
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From baseline to 3 years post treatment
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Mean change in patient reported outcomes using the Montreal Cognitive Assessment (MOCA) test from baseline up to 3 years post treatment.
Periodo de tiempo: From baseline to 3 years post treatment
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MOCA scores range between 0 and 30, with higher scores indicating higher cognitive function.
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From baseline to 3 years post treatment
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Mean change in patient reported outcomes using a stool survey measured from baseline and after 13 weeks of treatment.
Periodo de tiempo: From baseline to 13 weeks post-treatment.
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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.
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From baseline to 13 weeks post-treatment.
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Mean change in calories consumed using a 24-hour food diary from baseline and after 13 weeks of treatment.
Periodo de tiempo: From baseline to 13 weeks post-treatment
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From baseline to 13 weeks post-treatment
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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.
Periodo de tiempo: From baseline to 13 weeks post-treatment
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From baseline to 13 weeks post-treatment
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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.
Periodo de tiempo: From baseline to 13 weeks post-treatment
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From baseline to 13 weeks post-treatment
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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.
Periodo de tiempo: From baseline to 13 weeks post-treatment
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From baseline to 13 weeks post-treatment
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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.
Periodo de tiempo: From baseline to 13 weeks post-treatment
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From baseline to 13 weeks post-treatment
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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.
Periodo de tiempo: From baseline to 13 weeks post-treatment
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From baseline to 13 weeks post-treatment
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Inicio del estudio
Finalización primaria (Anticipado)
Finalización primaria
Finalización del estudio (Anticipado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- IIT2018-26 -Hendifar-NETCx
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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