- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02120417
A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
15. januar 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
149
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Cardiff, Det Forenede Kongerige
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Glasgow, Det Forenede Kongerige
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Kingston Upon Thames, Det Forenede Kongerige
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London, Det Forenede Kongerige
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Nottingham, Det Forenede Kongerige
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Sutton, Det Forenede Kongerige
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Taunton, Det Forenede Kongerige
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Truro, Det Forenede Kongerige
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Yeovil, Det Forenede Kongerige
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Alabama
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Birmingham, Alabama, Forenede Stater
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Arizona
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Chandler, Arizona, Forenede Stater
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Sedona, Arizona, Forenede Stater
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California
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La Jolla, California, Forenede Stater
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Los Angeles, California, Forenede Stater
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Oxnard, California, Forenede Stater
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San Diego, California, Forenede Stater
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San Francisco, California, Forenede Stater
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Santa Monica, California, Forenede Stater
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Colorado
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Aurora, Colorado, Forenede Stater
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Denver, Colorado, Forenede Stater
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Connecticut
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New Haven, Connecticut, Forenede Stater
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District of Columbia
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Washington, District of Columbia, Forenede Stater
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Florida
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Fort Myers, Florida, Forenede Stater
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Hialeah, Florida, Forenede Stater
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Miami, Florida, Forenede Stater
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Plantation, Florida, Forenede Stater
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Saint Petersburg, Florida, Forenede Stater
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Tampa, Florida, Forenede Stater
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Georgia
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Atlanta, Georgia, Forenede Stater
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Marietta, Georgia, Forenede Stater
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Savannah, Georgia, Forenede Stater
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Illinois
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Chicago, Illinois, Forenede Stater
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Quincy, Illinois, Forenede Stater
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Springfield, Illinois, Forenede Stater
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Urbana, Illinois, Forenede Stater
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Iowa
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Ames, Iowa, Forenede Stater
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Kansas
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Wichita, Kansas, Forenede Stater
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Kentucky
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Louisville, Kentucky, Forenede Stater
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater
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Maryland
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Baltimore, Maryland, Forenede Stater
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Michigan
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Detroit, Michigan, Forenede Stater
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Kalamazoo, Michigan, Forenede Stater
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Minnesota
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Duluth, Minnesota, Forenede Stater
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Minneapolis, Minnesota, Forenede Stater
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Missouri
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Kansas City, Missouri, Forenede Stater
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Saint Louis, Missouri, Forenede Stater
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Nebraska
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Grand Island, Nebraska, Forenede Stater
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Omaha, Nebraska, Forenede Stater
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New Jersey
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Camden, New Jersey, Forenede Stater
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Hackensack, New Jersey, Forenede Stater
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New Mexico
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Farmington, New Mexico, Forenede Stater
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New York
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Albany, New York, Forenede Stater
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Bronx, New York, Forenede Stater
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Johnson City, New York, Forenede Stater
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New York, New York, Forenede Stater
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North Carolina
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Goldsboro, North Carolina, Forenede Stater
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Pinehurst, North Carolina, Forenede Stater
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Ohio
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Canton, Ohio, Forenede Stater
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Cincinnati, Ohio, Forenede Stater
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Cleveland, Ohio, Forenede Stater
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Columbus, Ohio, Forenede Stater
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Middletown, Ohio, Forenede Stater
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Oregon
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Portland, Oregon, Forenede Stater
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater
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Philadelphia, Pennsylvania, Forenede Stater
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Pittsburgh, Pennsylvania, Forenede Stater
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South Carolina
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Charleston, South Carolina, Forenede Stater
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Greenville, South Carolina, Forenede Stater
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Tennessee
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Chattanooga, Tennessee, Forenede Stater
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Germantown, Tennessee, Forenede Stater
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Nashville, Tennessee, Forenede Stater
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Texas
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Arlington, Texas, Forenede Stater
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Bedford, Texas, Forenede Stater
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Dallas, Texas, Forenede Stater
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El Paso, Texas, Forenede Stater
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Fort Worth, Texas, Forenede Stater
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Houston, Texas, Forenede Stater
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McAllen, Texas, Forenede Stater
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Plano, Texas, Forenede Stater
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Tyler, Texas, Forenede Stater
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Utah
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Ogden, Utah, Forenede Stater
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Salt Lake City, Utah, Forenede Stater
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Virginia
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Fairfax, Virginia, Forenede Stater
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Norfolk, Virginia, Forenede Stater
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Richmond, Virginia, Forenede Stater
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Salem, Virginia, Forenede Stater
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Washington
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Seattle, Washington, Forenede Stater
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater
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Milwaukee, Wisconsin, Forenede Stater
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La Roche Sur Yon, Frankrig
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Paris, Frankrig
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Paris Cedex 10, Frankrig
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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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Treatment A - Capecitabine and ruxolitinib
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5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)
Andre navne:
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 matchende placebotabletter, der skal indgives gennem munden
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Overall Survival (OS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Progression-free Survival (PFS)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Gerard Kennealey, MD, Incyte Corporation
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2014
Primær færdiggørelse (Faktiske)
1. februar 2016
Studieafslutning (Faktiske)
1. januar 2017
Datoer for studieregistrering
Først indsendt
18. april 2014
Først indsendt, der opfyldte QC-kriterier
18. april 2014
Først opslået (Skøn)
22. april 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INCB 18424-268
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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