A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
15. januar 2018 oppdatert 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
149
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forente stater
-
-
Arizona
-
Chandler, Arizona, Forente stater
-
Sedona, Arizona, Forente stater
-
-
California
-
La Jolla, California, Forente stater
-
Los Angeles, California, Forente stater
-
Oxnard, California, Forente stater
-
San Diego, California, Forente stater
-
San Francisco, California, Forente stater
-
Santa Monica, California, Forente stater
-
-
Colorado
-
Aurora, Colorado, Forente stater
-
Denver, Colorado, Forente stater
-
-
Connecticut
-
New Haven, Connecticut, Forente stater
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater
-
-
Florida
-
Fort Myers, Florida, Forente stater
-
Hialeah, Florida, Forente stater
-
Miami, Florida, Forente stater
-
Plantation, Florida, Forente stater
-
Saint Petersburg, Florida, Forente stater
-
Tampa, Florida, Forente stater
-
-
Georgia
-
Atlanta, Georgia, Forente stater
-
Marietta, Georgia, Forente stater
-
Savannah, Georgia, Forente stater
-
-
Illinois
-
Chicago, Illinois, Forente stater
-
Quincy, Illinois, Forente stater
-
Springfield, Illinois, Forente stater
-
Urbana, Illinois, Forente stater
-
-
Iowa
-
Ames, Iowa, Forente stater
-
-
Kansas
-
Wichita, Kansas, Forente stater
-
-
Kentucky
-
Louisville, Kentucky, Forente stater
-
-
Louisiana
-
Baton Rouge, Louisiana, Forente stater
-
-
Maryland
-
Baltimore, Maryland, Forente stater
-
-
Michigan
-
Detroit, Michigan, Forente stater
-
Kalamazoo, Michigan, Forente stater
-
-
Minnesota
-
Duluth, Minnesota, Forente stater
-
Minneapolis, Minnesota, Forente stater
-
-
Missouri
-
Kansas City, Missouri, Forente stater
-
Saint Louis, Missouri, Forente stater
-
-
Nebraska
-
Grand Island, Nebraska, Forente stater
-
Omaha, Nebraska, Forente stater
-
-
New Jersey
-
Camden, New Jersey, Forente stater
-
Hackensack, New Jersey, Forente stater
-
-
New Mexico
-
Farmington, New Mexico, Forente stater
-
-
New York
-
Albany, New York, Forente stater
-
Bronx, New York, Forente stater
-
Johnson City, New York, Forente stater
-
New York, New York, Forente stater
-
-
North Carolina
-
Goldsboro, North Carolina, Forente stater
-
Pinehurst, North Carolina, Forente stater
-
-
Ohio
-
Canton, Ohio, Forente stater
-
Cincinnati, Ohio, Forente stater
-
Cleveland, Ohio, Forente stater
-
Columbus, Ohio, Forente stater
-
Middletown, Ohio, Forente stater
-
-
Oregon
-
Portland, Oregon, Forente stater
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Forente stater
-
Philadelphia, Pennsylvania, Forente stater
-
Pittsburgh, Pennsylvania, Forente stater
-
-
South Carolina
-
Charleston, South Carolina, Forente stater
-
Greenville, South Carolina, Forente stater
-
-
Tennessee
-
Chattanooga, Tennessee, Forente stater
-
Germantown, Tennessee, Forente stater
-
Nashville, Tennessee, Forente stater
-
-
Texas
-
Arlington, Texas, Forente stater
-
Bedford, Texas, Forente stater
-
Dallas, Texas, Forente stater
-
El Paso, Texas, Forente stater
-
Fort Worth, Texas, Forente stater
-
Houston, Texas, Forente stater
-
McAllen, Texas, Forente stater
-
Plano, Texas, Forente stater
-
Tyler, Texas, Forente stater
-
-
Utah
-
Ogden, Utah, Forente stater
-
Salt Lake City, Utah, Forente stater
-
-
Virginia
-
Fairfax, Virginia, Forente stater
-
Norfolk, Virginia, Forente stater
-
Richmond, Virginia, Forente stater
-
Salem, Virginia, Forente stater
-
-
Washington
-
Seattle, Washington, Forente stater
-
-
Wisconsin
-
Green Bay, Wisconsin, Forente stater
-
Milwaukee, Wisconsin, Forente stater
-
-
-
-
-
La Roche Sur Yon, Frankrike
-
Paris, Frankrike
-
Paris Cedex 10, Frankrike
-
-
-
-
-
Alba, Italia
-
Fano, Italia
-
Foggia, Italia
-
Lecco, Italia
-
Milano, Italia
-
Naples, Italia
-
Pontedera, Italia
-
Roma, Italia
-
Saronno, Italia
-
-
-
-
-
Lisbon, Portugal
-
-
-
-
-
A Coruña, Spania
-
Barcelona, Spania
-
Jaén, Spania
-
Lleida, Spania
-
Madrid, Spania
-
-
-
-
-
Cardiff, Storbritannia
-
Glasgow, Storbritannia
-
Kingston Upon Thames, Storbritannia
-
London, Storbritannia
-
Nottingham, Storbritannia
-
Sutton, Storbritannia
-
Taunton, Storbritannia
-
Truro, Storbritannia
-
Yeovil, Storbritannia
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment A - Capecitabine and ruxolitinib
|
5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)
Andre navn:
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
|
|
Aktiv komparator: Treatment B - Capecitabine and placebo
|
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 som skal administreres gjennom munnen
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Gerard Kennealey, MD, Incyte Corporation
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2014
Primær fullføring (Faktiske)
1. februar 2016
Studiet fullført (Faktiske)
1. januar 2017
Datoer for studieregistrering
Først innsendt
18. april 2014
Først innsendt som oppfylte QC-kriteriene
18. april 2014
Først lagt ut (Anslag)
22. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. februar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. januar 2018
Sist bekreftet
1. januar 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- INCB 18424-268
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .