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Brief Title: Study of Ruxolitinib in Colorectal Cancer Patients
Official Title: A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
Study ID: NCT02119676
Brief Summary: The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.
Detailed Description: The study consisted of an open-label, Part 1 safety run-in (consisting of 1 to 3 cohorts of 9 subjects each), to confirm the safety of the regorafenib/ruxolitinib combination in subjects with relapsed or refractory metastatic colorectal cancer (CRC). If determined to be tolerable, Part 2 was to proceed as a randomized, double-blind study evaluating ruxolitinib or placebo in combination with regorafenib in subjects with relapsed or refractory metastatic CRC previously treated with fluoropyrimidine, oxaliplatin, and/or irinotecan based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy and if Kirsten rat sarcoma (KRAS) wild type an anti-epidermal growth factor receptor (EGFR) therapy. Subjects in the safety run-in received open-label ruxolitinib and regorafenib; for the randomized, double-blind portion of the study all subjects received regorafenib and either ruxolitinib or placebo in a 1:1 blinded manner. Treatment for all subjects consisted of repeating 28-day cycles. Regorafenib was self-administered for the first 21 days of each cycle, and ruxolitinib/placebo was self-administered during the entire 28-day cycle. Treatment cycles continued as long as the regimen is tolerated, and the subject does not meet the discontinuation criteria. When subjects discontinued regorafenib, ruxolitinib or placebo they remained in the study and were followed for subsequent treatment regimens which were initiated and survival.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Chandler, Arizona, United States
, Gilbert, Arizona, United States
, Mesa, Arizona, United States
, Scottsdale, Arizona, United States
, Los Angeles, California, United States
, Pasadena, California, United States
, Santa Barbara, California, United States
, Aurora, Colorado, United States
, Colorado Springs, Colorado, United States
, Denver, Colorado, United States
, Altamonte Springs, Florida, United States
, Miami, Florida, United States
, Ocala, Florida, United States
, Orlando, Florida, United States
, Tampa, Florida, United States
, Niles, Illinois, United States
, Lafayette, Indiana, United States
, Ames, Iowa, United States
, New Orleans, Louisiana, United States
, Baltimore, Maryland, United States
, Jefferson City, Missouri, United States
, Saint Louis, Missouri, United States
, Lincoln, Nebraska, United States
, Omaha, Nebraska, United States
, Henderson, Nevada, United States
, Las Vegas, Nevada, United States
, Albany, New York, United States
, Binghamton, New York, United States
, Bronx, New York, United States
, Hudson, New York, United States
, Johnson City, New York, United States
, New York, New York, United States
, Canton, Ohio, United States
, Cincinnati, Ohio, United States
, Portland, Oregon, United States
, Charleston, South Carolina, United States
, Easley, South Carolina, United States
, Greenville, South Carolina, United States
, Greer, South Carolina, United States
, Sumter, South Carolina, United States
, Chattanooga, Tennessee, United States
, Nashville, Tennessee, United States
, Arlington, Texas, United States
, El Paso, Texas, United States
, Fort Worth, Texas, United States
, Houston, Texas, United States
, Paris, Texas, United States
, Plano, Texas, United States
, Tyler, Texas, United States
, American Fork, Utah, United States
, Bountiful, Utah, United States
, Murray, Utah, United States
, Provo, Utah, United States
, Salt Lake City, Utah, United States
, West Jordan, Utah, United States
, Roanoke, Virginia, United States
, Vancouver, Washington, United States
, Bentleigh East, , Australia
, Herston, , Australia
, Kurralta Park, , Australia
, New Lambton Heights, , Australia
, Randwick, , Australia
, Avignon Cedex 09, , France
, Besançon, , France
, Le Mans, , France
, Lille, , France
, Marseille Cedex 05, , France
, Paris, , France
, Augsburg, , Germany
, Halle, , Germany
, Hamburg, , Germany
, Beer Sheva, , Israel
, Haifa, , Israel
, Petah Tikva, , Israel
, Ramat Gan, , Israel
, Tel Aviv, , Israel
, Soeul, , Korea, Republic of
, Oviedo, Asturias, Spain
, Barcelona, , Spain
, Madrid, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Birmingham, , United Kingdom
, Bournemouth, , United Kingdom
, London, , United Kingdom
, Sutton, , United Kingdom
Name: Albert Assad
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR