A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
NCT ID: NCT02120417
Last Updated: 2018-02-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
149 participants
INTERVENTIONAL
2014-05-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment A - Capecitabine and ruxolitinib
Ruxolitinib
5 mg tablets to be administered by mouth
Ruxolitinib 15 mg BID (starting dose)
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
Treatment B - Capecitabine and placebo
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
Placebo
5 mg matching placebo tablets to be administered by mouth
Interventions
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Ruxolitinib
5 mg tablets to be administered by mouth
Ruxolitinib 15 mg BID (starting dose)
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
Placebo
5 mg matching placebo tablets to be administered by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gerard Kennealey, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Birmingham, Alabama, United States
Chandler, Arizona, United States
Sedona, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Oxnard, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Quincy, Illinois, United States
Springfield, Illinois, United States
Urbana, Illinois, United States
Ames, Iowa, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Grand Island, Nebraska, United States
Omaha, Nebraska, United States
Camden, New Jersey, United States
Hackensack, New Jersey, United States
Farmington, New Mexico, United States
Albany, New York, United States
Johnson City, New York, United States
New York, New York, United States
The Bronx, New York, United States
Goldsboro, North Carolina, United States
Pinehurst, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Middletown, Ohio, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Bedford, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
Plano, Texas, United States
Tyler, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Salem, Virginia, United States
Seattle, Washington, United States
Green Bay, Wisconsin, United States
Milwaukee, Wisconsin, United States
La Roche-sur-Yon, , France
Paris, , France
Alba, , Italy
Fano, , Italy
Foggia, , Italy
Lecco, , Italy
Milan, , Italy
Naples, , Italy
Pontedera, , Italy
Roma, , Italy
Saronno, , Italy
Lisbon, , Portugal
A Coruña, , Spain
Barcelona, , Spain
Jaén, , Spain
Lleida, , Spain
Madrid, , Spain
Cardiff, , United Kingdom
Glasgow, , United Kingdom
Kingston upon Thames, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Sutton, , United Kingdom
Taunton, , United Kingdom
Truro, , United Kingdom
Yeovil, , United Kingdom
Countries
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Other Identifiers
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INCB 18424-268
Identifier Type: -
Identifier Source: org_study_id
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