Study Stopped
The safety committee found no safety issues but recommended halting the study based on a lack of efficacy in a similar trial. The sponsor terminated the trial.
A Study of Ruxolitinib in Pancreatic Cancer Patients
A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 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 2 Study)
1 other identifier
interventional
86
14 countries
95
Brief Summary
This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pancreatic-cancer
Started Jun 2014
Shorter than P25 for phase_3 pancreatic-cancer
95 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
First Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
June 6, 2017
CompletedFebruary 13, 2018
January 1, 2018
1.7 years
April 17, 2014
February 6, 2017
January 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival is reported here based on the number of deaths from randomization until the data cut-off.
Randomization until death due to any cause up to 6-months or 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)
5 mg matching placebo tablets to be administered by mouth twice daily (BID)
150 mg or 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
- An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
- Criteria:
- mGPS of 1: C-reactive protein (CRP) \> 10 mg/L and albumin ≥ 35 g/L
- mGPS of 2: CRP \> 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
Unknown Facility
Huntsville, Alabama, United States
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Fayetteville, Arkansas, United States
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Beverly Hills, California, United States
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La Jolla, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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St. Petersburg, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Thomasville, Georgia, United States
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Harvey, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Minneapolis, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Bolivar, Missouri, United States
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Basking Ridge, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Commack, New York, United States
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Fresh Meadows, New York, United States
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Harrison, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Rockville Centre, New York, United States
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Sleepy Hollow, New York, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Salt Lake City, Utah, United States
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Falls Church, Virginia, United States
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Newport News, Virginia, United States
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Seattle, Washington, United States
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Green Bay, Wisconsin, United States
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Graz, Austria
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Wein, Austria
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Santiago, Chile
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Vitacura, Chile
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Bogotá, Colombia
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Medellín, Colombia
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Næstved, Denmark
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Odense C, Denmark
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Bordeaux, France
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Brest, France
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Dijon, France
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Lyon, France
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Nancy, France
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Cork, Ireland
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Dubin, Ireland
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Galway, Ireland
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Monterrey, Mexico
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Oaxaca City, Mexico
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Toluca, Mexico
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Amsterdam, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Braga, Portugal
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Lisbon, Portugal
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Porto, Portugal
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San Juan, Puerto Rico
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Linköping, Sweden
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Uppsala, Sweden
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Bellinzona, Switzerland
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Geneva, Switzerland
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 prior to the final analysis at the recommendation of the Data Monitoring Committee based on the review of efficacy in the 18424-362 (JANUS 1).
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Fitzroy Dawkins, MD
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 17, 2014
First Posted
April 22, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2016
Study Completion
October 1, 2016
Last Updated
February 13, 2018
Results First Posted
June 6, 2017
Record last verified: 2018-01