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A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer

7 de enero de 2015 actualizado por: Eli Lilly and Company

A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer

The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

15

Fase

  • Fase 2

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

      • Seoul, Corea, república de, 135 720
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Aichi, Japón, 464-8681
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Osaka, Japón, 565-0871
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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

20 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Have a diagnosis of a histopathologically or cytologically confirmed local and/or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma which is unresectable
  • Have received 2 regimens of prior chemotherapies for gastric or GEJ adenocarcinoma
  • Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Have consent to provide a tissue sample for pre-screening
  • Determined to be MET diagnostic positive based upon testing of a tumor sample obtained at any time before enrollment
  • Have discontinued all previous treatments for cancer, including chemotherapy and radiotherapy, for at least 3 weeks before enrollment and have recovered from the acute effects of therapy
  • Have adequate organ function
  • Male participants: must agree to use a reliable method of birth control and to not donate sperm during the study and for at least 4 months following last dose of study drug or country requirements, whichever is longer
  • Female participants: are women of child-bearing potential who test negative for pregnancy ≤14 days before enrollment based on a serum pregnancy test and agree to use a reliable method of birth control during the study and for 4 months following the last dose of the study drug and must also not be breastfeeding
  • Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have an estimated life expectancy, in the judgment of the investigator, of at least 12 weeks

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have previously completed or withdrawn from this study or any other study investigating LY2875358
  • Have an active fungal, bacterial, and/or known viral infection
  • Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction (MI) in 6 months prior to study drug administration
  • Have symptomatic central nervous system (CNS) malignancy or metastasis
  • Have previous or concurrent malignancies
  • Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C
  • Have corrected QT interval (QTc) of >470 millisecond (msec) on screening electrocardiogram (ECG)
  • Have received previous treatment with any hepatocyte growth factor (HGF)/MET targeting therapeutics
  • Have a history of radiation therapy involving more than 25% of the bone marrow. Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: LY2875358
LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle.
IV administrado

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Progression Free Survival (PFS) Rate
Periodo de tiempo: 8 Weeks
8 Weeks

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Periodo de tiempo: Baseline to Confirmed CR or PR (Estimated up to 4 Months)
Baseline to Confirmed CR or PR (Estimated up to 4 Months)
Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed CR or PR (Disease Control Rate [DCR])
Periodo de tiempo: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Duration of Response
Periodo de tiempo: Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Overall Survival (OS)
Periodo de tiempo: Baseline to Death from Any Cause (Estimated up to 6 Months)
Baseline to Death from Any Cause (Estimated up to 6 Months)
Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358
Periodo de tiempo: Baseline to Study Completion (Estimated up to 4 Months)
Baseline to Study Completion (Estimated up to 4 Months)
Pharmacokinetics (PK): Volume of distribution (V) of LY287358
Periodo de tiempo: Baseline to Study Completion (Estimated up to 4 Months)
Baseline to Study Completion (Estimated up to 4 Months)
PFS
Periodo de tiempo: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)
Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

1 de agosto de 2013

Finalización primaria (Actual)

1 de agosto de 2014

Finalización del estudio (Actual)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2013

Primero enviado que cumplió con los criterios de control de calidad

7 de junio de 2013

Publicado por primera vez (Estimar)

11 de junio de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de enero de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

7 de enero de 2015

Última verificación

1 de enero de 2015

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 15007
  • I4C-JE-JTBE (Otro identificador: Eli Lilly and Company)

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 Cáncer gástrico

Ensayos clínicos sobre LY2875358

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