Study Stopped
The study was terminated early based on the results of the planned interim analysis.
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)
1 other identifier
interventional
321
12 countries
230
Brief Summary
Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pancreatic-cancer
Started Mar 2014
Shorter than P25 for phase_3 pancreatic-cancer
230 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
July 11, 2017
CompletedMarch 26, 2019
March 1, 2019
1.9 years
April 16, 2014
February 9, 2017
March 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
Randomization until death due to any cause; up to the data cutoff 11FEB2016.
Secondary Outcomes (5)
Progression-free Survival (PFS)
Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Percentage of Participants Achieving Progression Free Survival (PFS)
Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Objective Response Rate (ORR)
Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Duration of Response
Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Participants With Treatment-Emergent Adverse Events (TEAEs)
Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
Study Arms (2)
Ruxolitinib plus capecitabine
EXPERIMENTALPlacebo plus capecitabine
ACTIVE COMPARATORInterventions
5 mg tablets to be administered by mouth twice daily (BID)
150 and 500 mg tablets to be administered by mouth twice daily (BID)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (230)
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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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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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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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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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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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Newark, Delaware, United States
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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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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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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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Goshen, Indiana, United States
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Indianapolis, Indiana, United States
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Topeka, Kansas, United States
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Ashland, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Scarborough, Maine, United States
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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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Worcester, Massachusetts, United States
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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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Woodbury, Minnesota, United States
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Bolivar, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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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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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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East Orange, New Jersey, United States
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Farmington, New Mexico, United States
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Binghamton, 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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The Bronx, New York, United States
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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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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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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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Philadelphia, Pennsylvania, United States
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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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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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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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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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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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Seattle, Washington, United States
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Vancouver, Washington, United States
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Madison, Wisconsin, United States
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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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Bruges, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Gilly, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Calgary, Alberta, Canada
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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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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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Cologne, Germany
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Essen, Germany
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Frankford, 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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Florence, Italy
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Genova, Italy
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Lido di Camaiore, Italy
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Milan, 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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Auckland, New Zealand
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Christchurch, New Zealand
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Hamilton, New Zealand
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Hwasun-gun, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Badajoz, Spain
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Barcelona, Spain
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Madrid, Spain
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Málaga, 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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Metropolitan Borough of Wirral, 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
Related Publications (1)
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.
PMID: 29508247DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation at the recommendation of the Data Monitoring Committee.
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Fitzroy Dawkins, M.D.
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2014
First Posted
April 21, 2014
Study Start
March 1, 2014
Primary Completion
February 1, 2016
Study Completion
December 1, 2016
Last Updated
March 26, 2019
Results First Posted
July 11, 2017
Record last verified: 2019-03