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Incyte Corporation

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
Estimated Enrollment: 373
Study Start Date: March 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02119676?term=jakafi&cond=colorec...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Jakafi (Ruxolitinib) (INCB-18424) (oral) Colorectal Ca.OncologyColorectal CancerJanus-associated Kinase InhibitorsJanus-associated Kinase

Mechanism of action: Jakafi (Ruxolitinib) (INCB-18424), a SM-inhibitor, reduces cell proliferation by disrupting the signaling of the Janus-associated kinases (JAK) pathway. Aberrant activation of the JAK-STAT pathway has been documented in a variety of cancers.

Phase of Development: II

Event Type: Data: Phase II trial results

Dates: 2016-07-01 - 2016-10-31

Results:

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Incyte Announces Decision to Stop Phase 2 Sub-study of Ruxolitinib Plus Regorafenib in Patients with Metastatic Colorectal Cancer and High CRP
WILMINGTON, Del.--(BUSINESS WIRE)--Jan. 27, 2016-- Incyte Corporation (Nasdaq: INCY) announced today that the Phase 2 sub-study of ruxolitinib or placebo in combination with regorafenib in patients with relapsed or refractory metastatic colorectal cancer (CRC) and high C-reactive protein (CRP) will be stopped early. The decision to stop the sub-study was made after a planned interim analysis of the high CRP subgroup demonstrated that ruxolitinib plus regorafenib did not show a sufficient level of efficacy to warrant continuation.
“We are disappointed at the outcome from this interim analysis and deeply grateful for the support and commitment of the patients participating in the study, their families, and the study investigators,” said Steven Stein, M.D., Chief Medical Officer of Incyte.
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Source: press release, 1/27/16. http://www.incyte.com/ir/investor-overview/press-releases/

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