Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
86 participants
INTERVENTIONAL
2014-06-30
2016-10-31
Brief Summary
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Detailed Description
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* Treatment A (N = 135): Capecitabine + ruxolitinib
* Treatment B (N = 135): Capecitabine + placebo
Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered during the entire cycle. Treatment for all participants was to continue as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued treatment continued to be followed for subsequent anticancer treatments and survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ruxolitinib plus capecitabine
Ruxolitinib
5 mg tablets to be administered by mouth twice daily (BID)
Capecitabine
150 mg or 500 mg tablets to be administered by mouth twice daily (BID)
Placebo plus capecitabine
Placebo
5 mg matching placebo tablets to be administered by mouth twice daily (BID)
Capecitabine
150 mg or 500 mg tablets to be administered by mouth twice daily (BID)
Interventions
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Ruxolitinib
5 mg tablets to be administered by mouth twice daily (BID)
Placebo
5 mg matching placebo tablets to be administered by mouth twice daily (BID)
Capecitabine
150 mg or 500 mg tablets to be administered by mouth twice daily (BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
* ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
* Radiographically measurable or evaluable disease
* An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
* Criteria:
1. mGPS of 1: C-reactive protein (CRP) \> 10 mg/L and albumin ≥ 35 g/L
2. mGPS of 2: CRP \> 10 mg/L and albumin \< 35 g/L
Exclusion Criteria
* Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment
* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
* Current or previous other malignancy within 2 years of study entry without sponsor approval
* Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), ruxolitinib, or any of their excipients.
* Prior treatment with a JAK inhibitor for any indication.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Fitzroy Dawkins, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Huntsville, Alabama, United States
Fayetteville, Arkansas, United States
Beverly Hills, California, United States
La Jolla, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
St. Petersburg, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Thomasville, Georgia, United States
Harvey, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Farmington Hills, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Minneapolis, Minnesota, United States
Saint Louis Park, Minnesota, United States
Bolivar, Missouri, United States
Basking Ridge, New Jersey, United States
Cherry Hill, New Jersey, United States
Voorhees Township, New Jersey, United States
Commack, New York, United States
Fresh Meadows, New York, United States
Harrison, New York, United States
New York, New York, United States
Rochester, New York, United States
Rockville Centre, New York, United States
Sleepy Hollow, New York, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Hershey, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Falls Church, Virginia, United States
Newport News, Virginia, United States
Seattle, Washington, United States
Green Bay, Wisconsin, United States
Graz, , Austria
Linz, , Austria
Salzburg, , Austria
Vienna, , Austria
Wein, , Austria
Santiago, , Chile
Vitacura, , Chile
Bogotá, , Colombia
Medellín, , Colombia
Næstved, , Denmark
Odense C, , Denmark
Bordeaux, , France
Brest, , France
Dijon, , France
Lyon, , France
Nancy, , France
Cork, , Ireland
Dubin, , Ireland
Galway, , Ireland
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Monterrey, , Mexico
Oaxaca City, , Mexico
Toluca, , Mexico
Amsterdam, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Braga, , Portugal
Lisbon, , Portugal
Porto, , Portugal
San Juan, , Puerto Rico
Linköping, , Sweden
Uppsala, , Sweden
Bellinzona, , Switzerland
Geneva, , Switzerland
Countries
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References
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Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.
Other Identifiers
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INCB 18424-363
Identifier Type: -
Identifier Source: org_study_id
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