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A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

15 gennaio 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

149

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • La Roche Sur Yon, Francia
      • Paris, Francia
      • Paris Cedex 10, Francia
  • Italia
      • Alba, Italia
      • Fano, Italia
      • Foggia, Italia
      • Lecco, Italia
      • Milano, Italia
      • Naples, Italia
      • Pontedera, Italia
      • Roma, Italia
      • Saronno, Italia
  • Portogallo
      • Lisbon, Portogallo
  • Regno Unito
      • Cardiff, Regno Unito
      • Glasgow, Regno Unito
      • Kingston Upon Thames, Regno Unito
      • London, Regno Unito
      • Nottingham, Regno Unito
      • Sutton, Regno Unito
      • Taunton, Regno Unito
      • Truro, Regno Unito
      • Yeovil, Regno Unito
  • Spagna
      • A Coruña, Spagna
      • Barcelona, Spagna
      • Jaén, Spagna
      • Lleida, Spagna
      • Madrid, Spagna
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti
    • Arizona
      • Chandler, Arizona, Stati Uniti
      • Sedona, Arizona, Stati Uniti
    • California
      • La Jolla, California, Stati Uniti
      • Los Angeles, California, Stati Uniti
      • Oxnard, California, Stati Uniti
      • San Diego, California, Stati Uniti
      • San Francisco, California, Stati Uniti
      • Santa Monica, California, Stati Uniti
    • Colorado
      • Aurora, Colorado, Stati Uniti
      • Denver, Colorado, Stati Uniti
    • Connecticut
      • New Haven, Connecticut, Stati Uniti
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti
    • Florida
      • Fort Myers, Florida, Stati Uniti
      • Hialeah, Florida, Stati Uniti
      • Miami, Florida, Stati Uniti
      • Plantation, Florida, Stati Uniti
      • Saint Petersburg, Florida, Stati Uniti
      • Tampa, Florida, Stati Uniti
    • Georgia
      • Atlanta, Georgia, Stati Uniti
      • Marietta, Georgia, Stati Uniti
      • Savannah, Georgia, Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti
      • Quincy, Illinois, Stati Uniti
      • Springfield, Illinois, Stati Uniti
      • Urbana, Illinois, Stati Uniti
    • Iowa
      • Ames, Iowa, Stati Uniti
    • Kansas
      • Wichita, Kansas, Stati Uniti
    • Kentucky
      • Louisville, Kentucky, Stati Uniti
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti
    • Michigan
      • Detroit, Michigan, Stati Uniti
      • Kalamazoo, Michigan, Stati Uniti
    • Minnesota
      • Duluth, Minnesota, Stati Uniti
      • Minneapolis, Minnesota, Stati Uniti
    • Missouri
      • Kansas City, Missouri, Stati Uniti
      • Saint Louis, Missouri, Stati Uniti
    • Nebraska
      • Grand Island, Nebraska, Stati Uniti
      • Omaha, Nebraska, Stati Uniti
    • New Jersey
      • Camden, New Jersey, Stati Uniti
      • Hackensack, New Jersey, Stati Uniti
    • New Mexico
      • Farmington, New Mexico, Stati Uniti
    • New York
      • Albany, New York, Stati Uniti
      • Bronx, New York, Stati Uniti
      • Johnson City, New York, Stati Uniti
      • New York, New York, Stati Uniti
    • North Carolina
      • Goldsboro, North Carolina, Stati Uniti
      • Pinehurst, North Carolina, Stati Uniti
    • Ohio
      • Canton, Ohio, Stati Uniti
      • Cincinnati, Ohio, Stati Uniti
      • Cleveland, Ohio, Stati Uniti
      • Columbus, Ohio, Stati Uniti
      • Middletown, Ohio, Stati Uniti
    • Oregon
      • Portland, Oregon, Stati Uniti
    • Pennsylvania
      • Bethlehem, Pennsylvania, Stati Uniti
      • Philadelphia, Pennsylvania, Stati Uniti
      • Pittsburgh, Pennsylvania, Stati Uniti
    • South Carolina
      • Charleston, South Carolina, Stati Uniti
      • Greenville, South Carolina, Stati Uniti
    • Tennessee
      • Chattanooga, Tennessee, Stati Uniti
      • Germantown, Tennessee, Stati Uniti
      • Nashville, Tennessee, Stati Uniti
    • Texas
      • Arlington, Texas, Stati Uniti
      • Bedford, Texas, Stati Uniti
      • Dallas, Texas, Stati Uniti
      • El Paso, Texas, Stati Uniti
      • Fort Worth, Texas, Stati Uniti
      • Houston, Texas, Stati Uniti
      • McAllen, Texas, Stati Uniti
      • Plano, Texas, Stati Uniti
      • Tyler, Texas, Stati Uniti
    • Utah
      • Ogden, Utah, Stati Uniti
      • Salt Lake City, Utah, Stati Uniti
    • Virginia
      • Fairfax, Virginia, Stati Uniti
      • Norfolk, Virginia, Stati Uniti
      • Richmond, Virginia, Stati Uniti
      • Salem, Virginia, Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti
    • Wisconsin
      • Green Bay, Wisconsin, Stati Uniti
      • Milwaukee, Wisconsin, Stati Uniti

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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:

      1. modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
      2. 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Treatment A - Capecitabine and ruxolitinib
Droga: Ruxolitinib

5 mg tablets to be administered by mouth

Ruxolitinib 15 mg BID (starting dose)

Altri nomi:
  • Jakafi®
  • Jakavi®
Droga: Capecitabine
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
Comparatore attivo: Treatment B - Capecitabine and placebo
Droga: Capecitabine
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
Droga: Placebo
Compresse placebo corrispondenti da 5 mg da somministrare per via orale

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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.
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Median Survival
Lasso di tempo: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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.
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Percentage of Participants Achieving Overall Survival
Lasso di tempo: Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
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.
Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS)
Lasso di tempo: Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
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.
Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
Percentage of Participants Achieving Objective Response Rate
Lasso di tempo: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Duration of Response (DOR)
Lasso di tempo: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Percentage of Participants Achieving Clinical Benefit Rate
Lasso di tempo: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Incyte Corporation

Investigatori

  • Direttore dello studio: Gerard Kennealey, MD, Incyte Corporation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2014

Completamento primario (Effettivo)

1 febbraio 2016

Completamento dello studio (Effettivo)

1 gennaio 2017

Date di iscrizione allo studio

Primo inviato

18 aprile 2014

Primo inviato che soddisfa i criteri di controllo qualità

18 aprile 2014

Primo Inserito (Stima)

22 aprile 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 febbraio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 gennaio 2018

Ultimo verificato

1 gennaio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • INCB 18424-268

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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