['colorectal neoplasms']
['rrx-001', 'regorafenib', 'irinotecan']

        Inclusion Criteria:

          -  Histological or cytological documentation of adenocarcinoma of the colon or rectum;

          -  Subject must have received at least oxaliplatin-, and irinotecan-based regimens with
             bevacizumab and with, cetuximab or panitumumab if KRAS wildtype and are refractory to
             irinotecan;

          -  Subject has measurable disease by radiographic techniques (computerized tomography
             [CT] or magnetic resonance imaging [MRI]);

          -  Subjects with a history of brain metastasis are eligible for the study as long as they
             meet all the following criteria: their brain metastases have been treated, they have
             no evidence of progression or hemorrhage after treatment, have been off dexamethasone
             for 4 weeks prior to first study drug administration, and have no ongoing requirement
             for dexamethasone or anti-epileptic drugs;

          -  Life expectancy of at least 12 weeks

          -  Subject's Eastern Cooperative Group (ECOG) performance status is 0 or 1;

          -  Adequate organ function

          -  Fertile subjects must use effective contraception during the course of the study and
             for 30 days following withdrawal from the study;

        Exclusion Criteria:

          -  Clinically significant cardiovascular disease;

          -  Unresolved toxicity higher attributed to any prior therapy/procedure excluding
             alopecia, hypothyroidism and oxaliplatin- induced neurotoxicity ≤ Grade 2 for at least
             14 days;

          -  Evidence or history of tendency or predisposition to active bleeding. Any hemorrhage
             or bleeding event of Grade 3 or higher within 4 weeks of start of study medication;

          -  Symptoms or signs of active brain metastases;

          -  History of an allergic reaction or intolerance to irinotecan

          -  Hepatic encephalopathy

          -  Cholangitis that required treatment or intervention within 4 weeks of study enrollment

          -  Concurrent anticancer therapy or any cytotoxic therapy within 1 month prior to Day 1.
             Corticosteroid therapy is not allowed except on dosing days;

          -  Subject has previously received regorafenib;

          -  Clear contraindication for systemic corticosteroids (diabetes mellitus is not per se a
             clear contraindication);

          -  Severe hypoalbuminemia (albumin < 3.0 g/dL);

          -  Subjects who are pregnant or lactating or who are planning to become pregnant during
             the course of the study are excluded.
      