CRC (Colorectal Cancer) Clinical Trial
Official title:
A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
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.
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.
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