Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
NCT ID: NCT02117479
Last Updated: 2019-03-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
321 participants
INTERVENTIONAL
2014-03-31
2016-12-31
Brief Summary
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Detailed Description
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* 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.
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 and 500 mg tablets to be administered by mouth twice daily (BID)
Placebo plus capecitabine
Placebo
5 mg tablets to be administered by mouth twice daily (BID)
Capecitabine
150 and 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 tablets to be administered by mouth twice daily (BID)
Capecitabine
150 and 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
* Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
1. mGPS of 1: C-reactive protein \>10 mg/L and albumin ≥35 g/L
2. mGPS of 2: C-reactive protein \>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).
* 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.
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, M.D.
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Avondale, Arizona, United States
Chandler, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Surprise, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Anaheim, California, United States
Bakersfield, California, United States
Berkeley, California, United States
Beverly Hills, California, United States
Chula Vista, California, United States
Covina, California, United States
Downey, California, United States
El Cajon, California, United States
Fullerton, California, United States
Gilroy, California, United States
Glendale, California, United States
La Mesa, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Lynwood, California, United States
Modesto, California, United States
Montebello, California, United States
Northridge, California, United States
Oceanside, California, United States
Orange, California, United States
Redondo Beach, California, United States
San Diego, California, United States
San Francisco, California, United States
San Luis Obispo, California, United States
Santa Ana, California, United States
Santa Maria, California, United States
Santa Monica, California, United States
Torrance, California, United States
Whittier, California, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Grand Junction, Colorado, United States
Longmont, Colorado, United States
Thornton, Colorado, United States
New Britain, Connecticut, United States
New Haven, Connecticut, United States
Southington, Connecticut, United States
Trumbull, Connecticut, United States
Newark, Delaware, United States
Boca Raton, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Austell, Georgia, United States
Carrollton, Georgia, United States
Cartersville, Georgia, United States
Douglasville, Georgia, United States
Marietta, Georgia, United States
Newnan, Georgia, United States
Rome, Georgia, United States
Thomasville, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Hinsdale, Illinois, United States
Niles, Illinois, United States
Urbana, Illinois, United States
Goshen, Indiana, United States
Indianapolis, Indiana, United States
Topeka, Kansas, United States
Ashland, Kentucky, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Scarborough, Maine, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Rockville, Maryland, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Woodbury, Minnesota, United States
Bolivar, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Kalispell, Montana, United States
Hastings, Nebraska, United States
Omaha, Nebraska, United States
Papillion, Nebraska, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
East Orange, New Jersey, United States
Farmington, New Mexico, United States
Binghamton, New York, United States
Fresh Meadows, New York, United States
Hudson, New York, United States
Johnson City, New York, United States
New York, New York, United States
Nyack, New York, United States
Rochester, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Wake Forest, North Carolina, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Columbus, Ohio, United States
Middletown, Ohio, United States
Oregon, Ohio, United States
Toledo, Ohio, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Springfield, Oregon, United States
Tualatin, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Seneca, South Carolina, United States
Spartanburg, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Beaumont, Texas, United States
Bedford, Texas, United States
Cedar Park, Texas, United States
Dallas, Texas, United States
Denton, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Round Rock, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Tyler, Texas, United States
Waco, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Blacksburg, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Salem, Virginia, United States
Wytheville, Virginia, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Madison, Wisconsin, United States
Australian Capital Territory, , Australia
New South Wales, , Australia
South Australia, , Australia
Victoria, , Australia
Aalst, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Gilly, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Calgary, Alberta, Canada
Oshawa, Ontario, Canada
Sault Ste. Marie, Ontario, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Laval, Quebec, Canada
Montreal, Quebec, Canada
Aschaffenburg, , Germany
Berlin, , Germany
Bochum, , Germany
Cologne, , Germany
Essen, , Germany
Frankford, , Germany
Velbert, , Germany
Aviano, , Italy
Bari, , Italy
Bergamo, , Italy
Brescia, , Italy
Cremona, , Italy
Florence, , Italy
Genova, , Italy
Lido di Camaiore, , Italy
Milan, , Italy
Napoli, , Italy
Pisa, , Italy
Rimini, , Italy
Roma, , Italy
Auckland, , New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
Hwasun-gun, , South Korea
Seongnam-si, , South Korea
Seoul, , South Korea
Badajoz, , Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Seville, , Spain
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Patumwan, , Thailand
Ratchathewi, , Thailand
Seetatarom, , Thailand
Aberdeen, , United Kingdom
Bangor, , United Kingdom
Birmingham, , United Kingdom
Boston, , United Kingdom
Bristol, , United Kingdom
Cardiff, , United Kingdom
Glasgow, , United Kingdom
Guildford, , United Kingdom
Harlow, , United Kingdom
Huddersfield, , United Kingdom
Lancaster, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Nottingham, , United Kingdom
Plymouth, , United Kingdom
Southampton, , United Kingdom
Sutton, , United Kingdom
Welwyn Garden City, , United Kingdom
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 18424-362
Identifier Type: -
Identifier Source: org_study_id
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