A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
15 janvier 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
149
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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A Coruña, Espagne
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Barcelona, Espagne
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Jaén, Espagne
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Lleida, Espagne
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Madrid, Espagne
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La Roche Sur Yon, France
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Paris, France
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Paris Cedex 10, France
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Alba, Italie
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Fano, Italie
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Foggia, Italie
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Lecco, Italie
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Milano, Italie
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Naples, Italie
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Pontedera, Italie
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Roma, Italie
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Saronno, Italie
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Lisbon, Le Portugal
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Cardiff, Royaume-Uni
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Glasgow, Royaume-Uni
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Kingston Upon Thames, Royaume-Uni
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London, Royaume-Uni
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Nottingham, Royaume-Uni
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Sutton, Royaume-Uni
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Taunton, Royaume-Uni
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Truro, Royaume-Uni
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Yeovil, Royaume-Uni
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Alabama
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Birmingham, Alabama, États-Unis
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Arizona
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Chandler, Arizona, États-Unis
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Sedona, Arizona, États-Unis
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California
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La Jolla, California, États-Unis
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Los Angeles, California, États-Unis
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Oxnard, California, États-Unis
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San Diego, California, États-Unis
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San Francisco, California, États-Unis
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Santa Monica, California, États-Unis
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Colorado
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Aurora, Colorado, États-Unis
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Denver, Colorado, États-Unis
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Connecticut
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New Haven, Connecticut, États-Unis
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District of Columbia
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Washington, District of Columbia, États-Unis
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Florida
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Fort Myers, Florida, États-Unis
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Hialeah, Florida, États-Unis
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Miami, Florida, États-Unis
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Plantation, Florida, États-Unis
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Saint Petersburg, Florida, États-Unis
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Tampa, Florida, États-Unis
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Georgia
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Atlanta, Georgia, États-Unis
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Marietta, Georgia, États-Unis
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Savannah, Georgia, États-Unis
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Illinois
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Chicago, Illinois, États-Unis
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Quincy, Illinois, États-Unis
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Springfield, Illinois, États-Unis
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Urbana, Illinois, États-Unis
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Iowa
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Ames, Iowa, États-Unis
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Kansas
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Wichita, Kansas, États-Unis
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Kentucky
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Louisville, Kentucky, États-Unis
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Louisiana
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Baton Rouge, Louisiana, États-Unis
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Maryland
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Baltimore, Maryland, États-Unis
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Michigan
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Detroit, Michigan, États-Unis
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Kalamazoo, Michigan, États-Unis
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Minnesota
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Duluth, Minnesota, États-Unis
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Minneapolis, Minnesota, États-Unis
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Missouri
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Kansas City, Missouri, États-Unis
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Saint Louis, Missouri, États-Unis
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Nebraska
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Grand Island, Nebraska, États-Unis
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Omaha, Nebraska, États-Unis
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New Jersey
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Camden, New Jersey, États-Unis
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Hackensack, New Jersey, États-Unis
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New Mexico
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Farmington, New Mexico, États-Unis
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New York
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Albany, New York, États-Unis
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Bronx, New York, États-Unis
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Johnson City, New York, États-Unis
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New York, New York, États-Unis
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North Carolina
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Goldsboro, North Carolina, États-Unis
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Pinehurst, North Carolina, États-Unis
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Ohio
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Canton, Ohio, États-Unis
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Cincinnati, Ohio, États-Unis
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Cleveland, Ohio, États-Unis
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Columbus, Ohio, États-Unis
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Middletown, Ohio, États-Unis
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Oregon
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Portland, Oregon, États-Unis
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Pennsylvania
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Bethlehem, Pennsylvania, États-Unis
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Philadelphia, Pennsylvania, États-Unis
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Pittsburgh, Pennsylvania, États-Unis
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South Carolina
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Charleston, South Carolina, États-Unis
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Greenville, South Carolina, États-Unis
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Tennessee
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Chattanooga, Tennessee, États-Unis
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Germantown, Tennessee, États-Unis
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Nashville, Tennessee, États-Unis
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Texas
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Arlington, Texas, États-Unis
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Bedford, Texas, États-Unis
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Dallas, Texas, États-Unis
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El Paso, Texas, États-Unis
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Fort Worth, Texas, États-Unis
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Houston, Texas, États-Unis
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McAllen, Texas, États-Unis
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Plano, Texas, États-Unis
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Tyler, Texas, États-Unis
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Utah
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Ogden, Utah, États-Unis
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Salt Lake City, Utah, États-Unis
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Virginia
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Fairfax, Virginia, États-Unis
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Norfolk, Virginia, États-Unis
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Richmond, Virginia, États-Unis
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Salem, Virginia, États-Unis
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Washington
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Seattle, Washington, États-Unis
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Wisconsin
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Green Bay, Wisconsin, États-Unis
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Milwaukee, Wisconsin, États-Unis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Treatment A - Capecitabine and ruxolitinib
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5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)
Autres noms:
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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Comparateur actif: 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
Comprimés placebo correspondants à 5 mg à administrer par voie orale
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Overall Survival (OS)
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Progression-free Survival (PFS)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Gerard Kennealey, MD, Incyte Corporation
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mai 2014
Achèvement primaire (Réel)
1 février 2016
Achèvement de l'étude (Réel)
1 janvier 2017
Dates d'inscription aux études
Première soumission
18 avril 2014
Première soumission répondant aux critères de contrôle qualité
18 avril 2014
Première publication (Estimation)
22 avril 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 février 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 janvier 2018
Dernière vérification
1 janvier 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- INCB 18424-268
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .