Relative Bioavailability of Pimasertib in Cancer Patients
6 de julio de 2017 actualizado por: EMD Serono
A Multi-Center, Open-Label, Single 60 mg Dose, Two Period, Two Sequence Cross-Over Trial to Investigate the Relative Bioavailability of Two Solid Oral Pimasertib Formulations in Cancer Patients
This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial extension phase).
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
38
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Rockland, Massachusetts, Estados Unidos
- Please Contact U.S. Medical Information Located in
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Pathologically confirmed solid tumors, either refractory to standard therapy or for which no effective standard therapy is available, with a measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Disease conditions or concomitant medication that may significantly influence the conduct of the trial or an abnormal electrocardiogram (ECG) or blood pressure at Screening as defined in the protocol
- Treatment with strong inhibitors or inducers of cytochrome P450 2C19 (CYP2C19) and CYP3A4 including fruit juices or beverages containing these substances
- History of prior mitogen-activated protein kinase/extracellular signal-regulated kinase (MAPK/ERK) kinase (MEK) inhibitor exposure (including, pimasertib) or progression of disease on MEK inhibitors
- Evidence of a retinal vein occlusion (RVO) on fluorescein angiogram or a history of RVO
- Life expectancy of less than 12 weeks
- Other protocol defined exclusion criteria could apply
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Pimasertib Capsule/Pimasertib Tablet
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Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.
Otros nombres:
Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.
Otros nombres:
Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.
Otros nombres:
Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.
Otros nombres:
Subjects completing Part A to receive pimasertib capsule at a dose of 60 mg orally twice daily in cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
Otros nombres:
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Experimental: Pimasertib Tablet/Pimasertib Capsule
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Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.
Otros nombres:
Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.
Otros nombres:
Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.
Otros nombres:
Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.
Otros nombres:
Subjects completing Part A to receive pimasertib capsule at a dose of 60 mg orally twice daily in cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximum Observed Plasma Concentration (Cmax)
Periodo de tiempo: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Maximum observed plasma concentration (Cmax) was calculated for Part A Pimasertib 60 mg Capsule and tablet.
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Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUC 0-t)
Periodo de tiempo: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration was at or above the lower limit of quantification.
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Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-inf)
Periodo de tiempo: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Periodo de tiempo: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Apparent Terminal Half-life (t1/2)
Periodo de tiempo: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Apparent Total Body Clearance (CL/f)
Periodo de tiempo: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Apparent Volume of Distribution (Vz/f)
Periodo de tiempo: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
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Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Terminal Rate Constant (λz)
Periodo de tiempo: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
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Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
Periodo de tiempo: From the first dose of study drug administration until 30 days after the last dose of study drug administration, assessed up to 14 Months
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An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug administration until 30 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.
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From the first dose of study drug administration until 30 days after the last dose of study drug administration, assessed up to 14 Months
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Part B: Number of Subjects Who Experienced Complete Response (CR)
Periodo de tiempo: Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months
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CR as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 defined as disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm).
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Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months
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Part B: Number of Subjects Who Experienced Partial Response (PR)
Periodo de tiempo: Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months
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PR as per RECIST v1.1 defined as 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters.
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Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months
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Part B: Number of Subjects Who Experienced Stable Disease (SD)
Periodo de tiempo: Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months
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SD as per RECIST v1.1 defined as neither shrinkage to qualify for PR nor increase to qualify for progressive disease (PD) taking the smallest sum diameters on study as reference.
PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; PD = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.
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Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months
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Part B: Number of Subjects Who Experienced Progressive Disease (PD)
Periodo de tiempo: Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months
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PD as per RECIST v1.1 defined as 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.
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Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de noviembre de 2013
Finalización primaria (Actual)
31 de mayo de 2014
Finalización del estudio (Actual)
28 de febrero de 2015
Fechas de registro del estudio
Enviado por primera vez
8 de noviembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
18 de noviembre de 2013
Publicado por primera vez (Estimar)
25 de noviembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de agosto de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
6 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 200066-013
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Pimasertib Capsule (Part A)
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EMD SeronoMerck KGaA, Darmstadt, GermanyTerminadoMelanoma cutáneo maligno metastásico o localmente avanzado con mutación N-RasEstados Unidos, Suecia, Australia, Francia, Italia, Sudáfrica, España, Reino Unido, Alemania, Países Bajos, Israel, Nueva Zelanda, Bélgica, Suiza
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Merck KGaA, Darmstadt, GermanyMerck Serono Co., Ltd., JapanTerminado
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BeiGeneActivo, no reclutandoCáncer de nasofaringe recurrente o metastásicoPorcelana, Taiwán, Tailandia
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Merck KGaA, Darmstadt, GermanyMerck Serono S.A., GenevaTerminadoCáncer | Tumores sólidosFrancia, Bélgica, Australia, Países Bajos
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Day One Biopharmaceuticals, Inc.ReclutamientoMelanoma | Cáncer colonrectal | Tumor solido | Cáncer de pulmón de células no pequeñas | Cáncer de vejiga | Cáncer De Tiroides Papilar | Astrocitoma pilocítico | Carcinoma urotelial de vejiga | Adenocarcinoma de células no pequeñas | Mutación MEK | Mutación RAS | Carcinoma acinar de páncreas | Mutación RAF | Amplificación... y otras condicionesEstados Unidos, Canadá, Corea, república de, España, Australia, Bélgica, Francia