- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117479
Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups:
- Treatment A (N = 155): Capecitabine + ruxolitinib
- Treatment B (N = 155): 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 daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Australian Capital Territory, Australia
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New South Wales, Australia
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South Australia, Australia
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Victoria, Australia
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Aalst, Belgium
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Brugge, Belgium
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Bruxelles, Belgium
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Edegem, Belgium
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Gent, Belgium
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Gilly, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Alberta
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Calgary, Alberta, Canada
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Ontario
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Oshawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Aschaffenburg, Germany
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Berlin, Germany
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Bochum, Germany
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Essen, Germany
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Frankford, Germany
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Koeln, Germany
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Velbert, Germany
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Aviano, Italy
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Bari, Italy
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Bergamo, Italy
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Brescia, Italy
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Cremona, Italy
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Firenze, Italy
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Genova, Italy
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Lido di Camaiore, Italy
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Milano, Italy
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Napoli, Italy
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Pisa, Italy
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Rimini, Italy
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Roma, Italy
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Hwasun-gun, Korea, Republic of
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Seongnam-si, Korea, Republic of
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Seoul, Korea, Republic of
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Auckland, New Zealand
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Christchurch, New Zealand
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Hamilton, New Zealand
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Badajoz, Spain
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Barcelona, Spain
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Madrid, Spain
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Malaga, Spain
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Seville, Spain
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Patumwan, Thailand
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Ratchathewi, Thailand
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Seetatarom, Thailand
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Aberdeen, United Kingdom
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Bangor, United Kingdom
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Birmingham, United Kingdom
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Boston, United Kingdom
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Bristol, United Kingdom
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Cardiff, United Kingdom
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Glasgow, United Kingdom
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Guildford, United Kingdom
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Harlow, United Kingdom
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Huddersfield, United Kingdom
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Lancaster, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Southampton, United Kingdom
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Sutton, United Kingdom
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Welwyn Garden City, United Kingdom
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Wirral, United Kingdom
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Arizona
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Avondale, Arizona, United States
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Surprise, Arizona, United States
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Tucson, Arizona, United States
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Arkansas
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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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California
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Anaheim, California, United States
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Bakersfield, California, United States
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Berkeley, California, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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Covina, California, United States
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Downey, California, United States
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El Cajon, California, United States
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Fullerton, California, United States
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Gilroy, California, United States
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Glendale, California, United States
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La Mesa, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Lynwood, California, United States
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Modesto, California, United States
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Montebello, California, United States
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Northridge, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Redondo Beach, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Luis Obispo, California, United States
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Santa Ana, California, United States
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Santa Maria, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Whittier, California, United States
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Colorado
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Aurora, Colorado, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Grand Junction, Colorado, United States
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Longmont, Colorado, United States
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Thornton, Colorado, United States
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Connecticut
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New Britain, Connecticut, United States
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New Haven, Connecticut, United States
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Southington, Connecticut, United States
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Trumbull, Connecticut, United States
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Delaware
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Newark, Delaware, United States
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Florida
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Boca Raton, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Austell, Georgia, United States
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Carrollton, Georgia, United States
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Cartersville, Georgia, United States
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Douglasville, Georgia, United States
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Marietta, Georgia, United States
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Newnan, Georgia, United States
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Rome, Georgia, United States
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Thomasville, Georgia, United States
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Illinois
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Hinsdale, Illinois, United States
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Niles, Illinois, United States
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Urbana, Illinois, United States
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Indiana
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Goshen, Indiana, United States
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Indianapolis, Indiana, United States
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Kansas
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Topeka, Kansas, United States
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Kentucky
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Ashland, Kentucky, United States
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Louisville, Kentucky, United States
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Louisiana
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Maine
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Scarborough, Maine, United States
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Maryland
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Rockville, Maryland, United States
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Massachusetts
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Worcester, Massachusetts, United States
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Michigan
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Minnesota
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Woodbury, Minnesota, United States
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Missouri
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Bolivar, Missouri, United States
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Kansas City, Missouri, United States
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Saint Louis, Missouri, United States
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Montana
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Kalispell, Montana, United States
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Nebraska
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Hastings, Nebraska, United States
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Omaha, Nebraska, United States
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Papillion, Nebraska, United States
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Nevada
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Las Vegas, Nevada, United States
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New Hampshire
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Lebanon, New Hampshire, United States
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New Jersey
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East Orange, New Jersey, United States
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New Mexico
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Farmington, New Mexico, United States
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New York
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Binghamton, New York, United States
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Bronx, New York, United States
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Fresh Meadows, New York, United States
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Hudson, New York, United States
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Johnson City, New York, United States
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New York, New York, United States
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Nyack, New York, United States
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Rochester, New York, United States
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North Carolina
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Durham, North Carolina, United States
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Wake Forest, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Ohio
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Middletown, Ohio, United States
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Oregon, Ohio, United States
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Toledo, Ohio, United States
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Oregon
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Springfield, Oregon, United States
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Tualatin, Oregon, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Seneca, South Carolina, United States
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Spartanburg, South Carolina, United States
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Tennessee
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Arlington, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bedford, Texas, United States
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Cedar Park, Texas, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Utah
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Virginia
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Blacksburg, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Salem, Virginia, United States
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Wytheville, Virginia, United States
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Washington
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Seattle, Washington, United States
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Vancouver, Washington, United States
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Wisconsin
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Madison, Wisconsin, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas.
- 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
Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
- mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
- mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
Exclusion Criteria:
- Received more than 1 prior regimen for advanced or metastatic disease.
- 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).
- Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
- Prior treatment with a JAK inhibitor for any indication.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ruxolitinib plus capecitabine
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5 mg tablets to be administered by mouth twice daily (BID)
Other Names:
150 and 500 mg tablets to be administered by mouth twice daily (BID)
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Active Comparator: Placebo plus capecitabine
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150 and 500 mg tablets to be administered by mouth twice daily (BID)
5 mg tablets to be administered by mouth twice daily (BID)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Randomization until death due to any cause; up to the data cutoff 11FEB2016.
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Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
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Randomization until death due to any cause; up to the data cutoff 11FEB2016.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
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Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
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Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
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Percentage of Participants Achieving Progression Free Survival (PFS)
Time Frame: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
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PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner.
Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
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Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
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Objective Response Rate (ORR)
Time Frame: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
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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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Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
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Duration of Response
Time Frame: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
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Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.
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Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
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Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
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A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo).
A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication.
A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above.
The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
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Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fitzroy Dawkins, M.D., Incyte Corporation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- INCB 18424-362
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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