Spots Global Cancer Trial Database for A Study of Ruxolitinib in Pancreatic Cancer Patients
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Trial Identification
Brief Title: A Study of Ruxolitinib in Pancreatic Cancer Patients
Official Title: 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)
Study ID: NCT02119663
Conditions
Study Description
Brief Summary: This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.
Detailed Description: This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 270 participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were to be randomized (1:1) to one of the following treatment groups: * 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, 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, District of Columbia, United States
, Fort Myers, Florida, United States
, Saint 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, 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
, Bogota, , Colombia
, Medellin, , Colombia
, Naestved, , Denmark
, Odense C, , Denmark
, Bordeaux, , France
, Brest Cedex, , France
, Dijon, , France
, Lyon, , France
, Nancy, , France
, Cork, , Ireland
, Dubin, , Ireland
, Galway, , Ireland
, Beer Sheva, , Israel
, Haifa, , Israel
, Jerusalem, , Israel
, Petach Tikva, , Israel
, Ramat Gan, , Israel
, Tel Aviv, , Israel
, Tel Hashomer, , Israel
, Monterrey, , Mexico
, Oaxaca, , Mexico
, Toluca, , Mexico
, Amsterdam, , Netherlands
, Maastricht, , Netherlands
, Nijmegen, , Netherlands
, Braga, , Portugal
, Lisboa, , Portugal
, Porto, , Portugal
, San Juan, , Puerto Rico
, Linköping, , Sweden
, Uppsala, , Sweden
, Bellinzona, , Switzerland
, Geneve, , Switzerland
Contact Details
Name: Fitzroy Dawkins, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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