A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
15 de enero de 2018 actualizado por: Incyte Corporation
A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer
This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
149
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
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A Coruña, España
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Barcelona, España
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Jaén, España
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Lleida, España
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Madrid, España
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Alabama
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Birmingham, Alabama, Estados Unidos
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Arizona
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Chandler, Arizona, Estados Unidos
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Sedona, Arizona, Estados Unidos
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California
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La Jolla, California, Estados Unidos
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Los Angeles, California, Estados Unidos
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Oxnard, California, Estados Unidos
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San Diego, California, Estados Unidos
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San Francisco, California, Estados Unidos
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Santa Monica, California, Estados Unidos
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Colorado
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Aurora, Colorado, Estados Unidos
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Denver, Colorado, Estados Unidos
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Connecticut
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New Haven, Connecticut, Estados Unidos
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District of Columbia
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Washington, District of Columbia, Estados Unidos
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Florida
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Fort Myers, Florida, Estados Unidos
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Hialeah, Florida, Estados Unidos
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Miami, Florida, Estados Unidos
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Plantation, Florida, Estados Unidos
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Saint Petersburg, Florida, Estados Unidos
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Tampa, Florida, Estados Unidos
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Georgia
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Atlanta, Georgia, Estados Unidos
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Marietta, Georgia, Estados Unidos
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Savannah, Georgia, Estados Unidos
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Illinois
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Chicago, Illinois, Estados Unidos
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Quincy, Illinois, Estados Unidos
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Springfield, Illinois, Estados Unidos
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Urbana, Illinois, Estados Unidos
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Iowa
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Ames, Iowa, Estados Unidos
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Kansas
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Wichita, Kansas, Estados Unidos
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Kentucky
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Louisville, Kentucky, Estados Unidos
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos
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Maryland
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Baltimore, Maryland, Estados Unidos
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Michigan
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Detroit, Michigan, Estados Unidos
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Kalamazoo, Michigan, Estados Unidos
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Minnesota
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Duluth, Minnesota, Estados Unidos
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Minneapolis, Minnesota, Estados Unidos
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Missouri
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Kansas City, Missouri, Estados Unidos
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Saint Louis, Missouri, Estados Unidos
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Nebraska
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Grand Island, Nebraska, Estados Unidos
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Omaha, Nebraska, Estados Unidos
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New Jersey
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Camden, New Jersey, Estados Unidos
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Hackensack, New Jersey, Estados Unidos
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New Mexico
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Farmington, New Mexico, Estados Unidos
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New York
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Albany, New York, Estados Unidos
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Bronx, New York, Estados Unidos
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Johnson City, New York, Estados Unidos
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New York, New York, Estados Unidos
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North Carolina
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Goldsboro, North Carolina, Estados Unidos
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Pinehurst, North Carolina, Estados Unidos
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Ohio
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Canton, Ohio, Estados Unidos
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Cincinnati, Ohio, Estados Unidos
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Cleveland, Ohio, Estados Unidos
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Columbus, Ohio, Estados Unidos
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Middletown, Ohio, Estados Unidos
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Oregon
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Portland, Oregon, Estados Unidos
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Pennsylvania
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Bethlehem, Pennsylvania, Estados Unidos
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Philadelphia, Pennsylvania, Estados Unidos
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Pittsburgh, Pennsylvania, Estados Unidos
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South Carolina
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Charleston, South Carolina, Estados Unidos
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Greenville, South Carolina, Estados Unidos
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Tennessee
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Chattanooga, Tennessee, Estados Unidos
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Germantown, Tennessee, Estados Unidos
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Nashville, Tennessee, Estados Unidos
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Texas
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Arlington, Texas, Estados Unidos
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Bedford, Texas, Estados Unidos
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Dallas, Texas, Estados Unidos
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El Paso, Texas, Estados Unidos
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Fort Worth, Texas, Estados Unidos
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Houston, Texas, Estados Unidos
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McAllen, Texas, Estados Unidos
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Plano, Texas, Estados Unidos
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Tyler, Texas, Estados Unidos
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Utah
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Ogden, Utah, Estados Unidos
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Salt Lake City, Utah, Estados Unidos
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Virginia
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Fairfax, Virginia, Estados Unidos
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Norfolk, Virginia, Estados Unidos
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Richmond, Virginia, Estados Unidos
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Salem, Virginia, Estados Unidos
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Washington
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Seattle, Washington, Estados Unidos
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos
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Milwaukee, Wisconsin, Estados Unidos
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La Roche Sur Yon, Francia
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Paris, Francia
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Paris Cedex 10, Francia
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Alba, Italia
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Fano, Italia
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Foggia, Italia
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Lecco, Italia
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Milano, Italia
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Naples, Italia
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Pontedera, Italia
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Roma, Italia
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Saronno, Italia
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Lisbon, Portugal
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Cardiff, Reino Unido
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Glasgow, Reino Unido
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Kingston Upon Thames, Reino Unido
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London, Reino Unido
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Nottingham, Reino Unido
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Sutton, Reino Unido
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Taunton, Reino Unido
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Truro, Reino Unido
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Yeovil, Reino Unido
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
- Locally advanced (Stage 3B) or metastatic (Stage 4) disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
- Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
- ≥ 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
- Radiographically measurable or evaluable disease
An mGPS of 1 or 2 as defined below:
Criteria:
- modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
- mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
Exclusion Criteria:
- Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
- Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
- Unknown hormone-receptor status
- Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
- Concurrent anticancer therapy
- Inadequate renal, hepatic or bone marrow function
- Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
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 paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Treatment A - Capecitabine and ruxolitinib
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5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)
Otros nombres:
Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle
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Comparador activo: Treatment B - Capecitabine and placebo
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Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle
Comprimidos de placebo equivalentes de 5 mg para administrar por vía oral
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall Survival (OS)
Periodo de tiempo: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis.
The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.
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Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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Median Survival
Periodo de tiempo: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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Survival was assessed by the time to death or censoring up until 08Feb2016.
Participants with no observed death were treated as right-censored at their last date known to be alive.
The survival time was analyzed using the Kaplan-Meier method.
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Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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Percentage of Participants Achieving Overall Survival
Periodo de tiempo: Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
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Overall survival was assessed by the time to death or censoring up until 08Feb2016.
Participants with no observed death were treated as right-censored at their last date known to be alive.
The survival time was analyzed using the Kaplan-Meier method.
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Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression-free Survival (PFS)
Periodo de tiempo: Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
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Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier.
Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.
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Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
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Percentage of Participants Achieving Objective Response Rate
Periodo de tiempo: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
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Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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Duration of Response (DOR)
Periodo de tiempo: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement.
The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria.
The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria.
The date of progressive disease was the date on which progression was first recorded.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
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Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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Percentage of Participants Achieving Clinical Benefit Rate
Periodo de tiempo: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
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Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Gerard Kennealey, MD, Incyte Corporation
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)
1 de mayo de 2014
Finalización primaria (Actual)
1 de febrero de 2016
Finalización del estudio (Actual)
1 de enero de 2017
Fechas de registro del estudio
Enviado por primera vez
18 de abril de 2014
Primero enviado que cumplió con los criterios de control de calidad
18 de abril de 2014
Publicado por primera vez (Estimar)
22 de abril de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
15 de enero de 2018
Última verificación
1 de enero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INCB 18424-268
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. .