Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
396 participants
INTERVENTIONAL
2014-03-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ruxolitinib plus regorafenib
Ruxolitinib
5 mg tablets to be administered by mouth
Ruxolitinib 20 mg twice a day (BID) (Part 1) (NOTE: The starting dose for the randomized portion of study (Part 2) was 15 mg BID based on results from Part 1.)
Regorafenib
Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.)
Placebo plus regorafenib
Regorafenib
Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.)
Placebo
5 mg matching placebo tablets to be administered by mouth
Interventions
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Ruxolitinib
5 mg tablets to be administered by mouth
Ruxolitinib 20 mg twice a day (BID) (Part 1) (NOTE: The starting dose for the randomized portion of study (Part 2) was 15 mg BID based on results from Part 1.)
Regorafenib
Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.)
Placebo
5 mg matching placebo tablets to be administered by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous treatment with fluoropyrimidine-, oxaliplatin- and irinotecan- based chemotherapy, an anti-VEGF therapy (if no contraindication) and if KRAS wild type and no contraindication, an anti-EGFR therapy.
* Radiographically measurable or evaluable disease (per RECIST v1.1)
* Life expectancy of ≥ 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Three or more weeks have elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities.
* Prior radiotherapy to disease sites is allowed with certain protocol-defined restrictions.
Exclusion Criteria
* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
* Active peptic ulcer disease, inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.
* Recent history (≤ 3 months) or ongoing partial or complete bowel obstruction unless due to disease under study and corrected with surgery.
* Blood pressure ≥ 140/90 mmHg.
* Active bleeding diathesis or history of any major bleeding (eg, requiring transfusion of red blood cells (RBCs), central nervous system (CNS) bleeding, or significant hemoptysis within 6 months of enrollment. Subjects with bleeding secondary to underlying disease (including gastrointestinal (GI) perforation or fistula) that has been corrected by surgery or alternative procedure may be included.
* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class II, III, or IV congestive heart failure, and arrhythmia requiring therapy.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Albert Assad
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
St 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
Hudson, New York, United States
Johnson City, New York, United States
New York, New York, United States
The Bronx, 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, , France
Besançon, , France
Le Mans, , France
Lille, , France
Marseille, , France
Paris, , France
Augsburg, , Germany
Halle, , Germany
Hamburg, , Germany
Beersheba, , Israel
Haifa, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Soeul, , South Korea
Oviedo, Principality of Asturias, Spain
Barcelona, , Spain
Madrid, , Spain
Seville, , Spain
Valencia, , Spain
Birmingham, , United Kingdom
Bournemouth, , United Kingdom
London, , United Kingdom
Sutton, , United Kingdom
Countries
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Other Identifiers
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INCB18424-267
Identifier Type: -
Identifier Source: org_study_id
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