Study of Ruxolitinib in Colorectal Cancer Patients

Stopped early · Phase 2 · Has a placebo group

Conditions studied: CRC (Colorectal Cancer)

In brief

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.

Key facts

Study ID

NCT02119676

Run by

Incyte Corporation

People needed

396

Starts

2014-03-01

Expected to finish

2016-12-01

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic.
• 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.

You may not qualify if…

• Prior treatment with regorafenib.
• 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.

Where it is running

• Study site — Gilbert, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Altamonte Springs, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Niles, Illinois, United States
• Study site — Lafayette, Indiana, United States
• Study site — Ames, Iowa, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Jefferson City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Omaha, Nebraska, United States
• Study site — Henderson, Nevada, United States
• Study site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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