A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
Condition: Colon Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Regorafenib
Intervention description: Regorafenib orally for 21 days every 28 day cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an exploratory biomarker study. Patients with metastatic colorectal cancer will
      receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive
      28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after
      starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after
      starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic colorectal cancer suitable for regorafenib treatment

          -  Life expectancy of at least 12 weeks

          -  Able to understand and willing to sign written informed consent form

          -  Adequate bone marrow, liver, and renal function

          -  Glomerular filtration rate >/= 60 according to the Modified Diet in Renal Disease
             abbreviated formula

          -  Women of childbearing potential must have a negative serum pregnancy test

          -  Subject able to swallow and retain oral medication

        Exclusion Criteria:

          -  Previous assignment to treatment in this study

          -  Uncontrolled hypertension

          -  Active or clinically significant cardiac disease

          -  Evidence or history of Bleeding diathesis or coagulopathy

          -  Any hemorrhage or bleeding even Grade 3 or higher within 4 weeks prior to start of
             study medication

          -  Subjects with thrombotic, embolic, venous or arterial events

          -  Subjects with any previously untreated or concurrent cancer

          -  Pheochromocytoma

          -  Known history of human immunodeficiency virus infection or current chronic or active
             hepatitis B or C infection requiring treatment with antiviral therapy

          -  Ongoing infection Grade 2 or higher

          -  Symptomatic metastatic brain or meningeal tumors

          -  Presence of a non-healing wound, non-healing ulcer, or bone fracture

          -  Renal failure requiring dialysis

          -  Dehydration Grade 1 or higher

          -  Seizure disorder requiring medication

          -  Persistent proteinuria Grade 3 or higher

          -  Interstitial lung disease with ongoing signs and symptoms at the time of informed
             consent

          -  Pleural effusion or ascites that causes respiratory compromise

          -  History of organ allograft including corneal transplant

          -  Known or suspected allergy or hypersensitivity to the study drug

          -  Any malabsorption condition

          -  Women who are pregnancy or breast-feeding

          -  Substance abuse, medical, psychological or social conditions that may interfere with
             the subject's participation in the study or evaluation of the study results

          -  Concurrent anticancer therapy

          -  Concurrent use of another investigational drug or device therapy during or within 4
             weeks of trial entry

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             before start of study medication

          -  Therapeutic anticoagulation with Vitamin-K antagonists or with heparins and
             heparinoids

          -  Use of any herbal remedy