A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
15 januari 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
149
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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La Roche Sur Yon, Frankrike
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Paris, Frankrike
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Paris Cedex 10, Frankrike
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Alabama
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Birmingham, Alabama, Förenta staterna
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Arizona
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Chandler, Arizona, Förenta staterna
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Sedona, Arizona, Förenta staterna
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California
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La Jolla, California, Förenta staterna
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Los Angeles, California, Förenta staterna
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Oxnard, California, Förenta staterna
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San Diego, California, Förenta staterna
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San Francisco, California, Förenta staterna
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Santa Monica, California, Förenta staterna
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Colorado
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Aurora, Colorado, Förenta staterna
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Denver, Colorado, Förenta staterna
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Connecticut
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New Haven, Connecticut, Förenta staterna
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District of Columbia
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Washington, District of Columbia, Förenta staterna
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Florida
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Fort Myers, Florida, Förenta staterna
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Hialeah, Florida, Förenta staterna
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Miami, Florida, Förenta staterna
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Plantation, Florida, Förenta staterna
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Saint Petersburg, Florida, Förenta staterna
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Tampa, Florida, Förenta staterna
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Georgia
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Atlanta, Georgia, Förenta staterna
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Marietta, Georgia, Förenta staterna
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Savannah, Georgia, Förenta staterna
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Illinois
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Chicago, Illinois, Förenta staterna
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Quincy, Illinois, Förenta staterna
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Springfield, Illinois, Förenta staterna
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Urbana, Illinois, Förenta staterna
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Iowa
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Ames, Iowa, Förenta staterna
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Kansas
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Wichita, Kansas, Förenta staterna
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Kentucky
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Louisville, Kentucky, Förenta staterna
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna
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Maryland
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Baltimore, Maryland, Förenta staterna
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Michigan
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Detroit, Michigan, Förenta staterna
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Kalamazoo, Michigan, Förenta staterna
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Minnesota
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Duluth, Minnesota, Förenta staterna
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Minneapolis, Minnesota, Förenta staterna
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Missouri
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Kansas City, Missouri, Förenta staterna
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Saint Louis, Missouri, Förenta staterna
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Nebraska
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Grand Island, Nebraska, Förenta staterna
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Omaha, Nebraska, Förenta staterna
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New Jersey
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Camden, New Jersey, Förenta staterna
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Hackensack, New Jersey, Förenta staterna
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New Mexico
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Farmington, New Mexico, Förenta staterna
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New York
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Albany, New York, Förenta staterna
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Bronx, New York, Förenta staterna
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Johnson City, New York, Förenta staterna
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New York, New York, Förenta staterna
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North Carolina
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Goldsboro, North Carolina, Förenta staterna
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Pinehurst, North Carolina, Förenta staterna
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Ohio
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Canton, Ohio, Förenta staterna
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Cincinnati, Ohio, Förenta staterna
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Cleveland, Ohio, Förenta staterna
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Columbus, Ohio, Förenta staterna
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Middletown, Ohio, Förenta staterna
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Oregon
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Portland, Oregon, Förenta staterna
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Pennsylvania
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Bethlehem, Pennsylvania, Förenta staterna
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Philadelphia, Pennsylvania, Förenta staterna
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Pittsburgh, Pennsylvania, Förenta staterna
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South Carolina
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Charleston, South Carolina, Förenta staterna
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Greenville, South Carolina, Förenta staterna
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Tennessee
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Chattanooga, Tennessee, Förenta staterna
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Germantown, Tennessee, Förenta staterna
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Nashville, Tennessee, Förenta staterna
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Texas
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Arlington, Texas, Förenta staterna
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Bedford, Texas, Förenta staterna
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Dallas, Texas, Förenta staterna
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El Paso, Texas, Förenta staterna
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Fort Worth, Texas, Förenta staterna
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Houston, Texas, Förenta staterna
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McAllen, Texas, Förenta staterna
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Plano, Texas, Förenta staterna
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Tyler, Texas, Förenta staterna
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Utah
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Ogden, Utah, Förenta staterna
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Salt Lake City, Utah, Förenta staterna
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Virginia
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Fairfax, Virginia, Förenta staterna
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Norfolk, Virginia, Förenta staterna
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Richmond, Virginia, Förenta staterna
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Salem, Virginia, Förenta staterna
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Washington
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Seattle, Washington, Förenta staterna
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Wisconsin
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Green Bay, Wisconsin, Förenta staterna
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Milwaukee, Wisconsin, Förenta staterna
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Alba, Italien
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Fano, Italien
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Foggia, Italien
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Lecco, Italien
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Milano, Italien
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Naples, Italien
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Pontedera, Italien
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Roma, Italien
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Saronno, Italien
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Lisbon, Portugal
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A Coruña, Spanien
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Barcelona, Spanien
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Jaén, Spanien
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Lleida, Spanien
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Madrid, Spanien
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Cardiff, Storbritannien
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Glasgow, Storbritannien
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Kingston Upon Thames, Storbritannien
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London, Storbritannien
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Nottingham, Storbritannien
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Sutton, Storbritannien
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Taunton, Storbritannien
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Truro, Storbritannien
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Yeovil, Storbritannien
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Treatment A - Capecitabine and ruxolitinib
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5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)
Andra namn:
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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Aktiv komparator: 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
5 mg matchande placebotabletter som administreras via munnen
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Overall Survival (OS)
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Progression-free Survival (PFS)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Gerard Kennealey, MD, Incyte Corporation
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2014
Primärt slutförande (Faktisk)
1 februari 2016
Avslutad studie (Faktisk)
1 januari 2017
Studieregistreringsdatum
Först inskickad
18 april 2014
Först inskickad som uppfyllde QC-kriterierna
18 april 2014
Första postat (Uppskatta)
22 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 februari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- INCB 18424-268
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .