Regorafenib in Metastatic Colorectal Cancer

Subjects will be asked to participate in the study because they are aged 70 or older and
require treatment for colorectal cancer that has spread to other parts of the body and has
not gotten better with other treatment. Subjects will undergo some initial tests to ensure
that they meet all criteria necessary to participate in the study. Once the subject has
completed initial testing and meets eligibility criteria, the subject will begin treatment
with 120 mg of regorafenib (3 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4
weeks). After the first cycle, the doctor will discuss the possibility of increasing the dose
to 160 mg (4 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks) based on the
subjects health status. During the study, assessments will be performed to monitor the
subjects tolerance and response to the treatment. Regorafenib will continue as long as the
subject is tolerating the treatment and the subjects colorectal cancer is either responding
to treatment or remains stable.

Inclusion Criteria:

- Histologically confirmed colorectal adenocarcinoma

- Measurable metastatic disease.

- Age +/> 70

- Progression on standard therapy, not a candidate for further chemotherapy or patient
declines other options

- Life expectancy >/= 12 weeks

- Able to understand and willing to sign written informed consent.

- Laboratory requirements:

- Total bili ≤ 1.5 x upper limit or normal

- Alanine aminotransferase & Asparate aminotransferase ≤ 2.5 x upper limit or normal

- Serum creatinine ≤ 1.5 x upper limit or normal

- International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal

- Platelet count ≥ 100,000, hemoglobin ≥ 9 g/dL

- Absolute neutrophil count ≥ 1,500. Blood transfusion to meet the inclusion criteria
not be allowed.

- Glomerular filtration rate ≥ 60 ml/min

- Subjects of childbearing potential must agree to use adequate contraception beginning
at the signing informed consent form until at least 3 months after the last dose of
study drug.

- Must be able to swallow and retain oral medications

Exclusion Criteria:

- Currently receiving other systemic therapy for metastatic colorectal cancer

- Previous assignment to treatment during this study. Subjects permanently withdrawn
from study participation will not be allowed to re-enter study.

- Uncontrolled hypertension despite optimal medical management

- Active or clinically significant cardiac disease.

- Evidence or history of bleeding diathesis or coagulopathy

- Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks.

- Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular
accident, deep vein thrombosis or pulmonary embolus within 6 months of informed
consent

- History of other active malignancy within past 2 years.

- Patients with phaeochromocytoma

- Known history of human immunodeficiency virus infection or current chronic/active
hepatitis B or C infection.

- Ongoing infection > grade 2

- Symptomatic metastatic brain or meningeal tumors

- Presence of non-healing wound, non-healing ulcer, or bone fracture

- Renal failure requiring hemo- or peritoneal dialysis

- Dehydration ≥ grade 1

- Patients with seizure disorder requiring medication

- Persistent proteinuria ≥ grade 3 Interstitial lung disease with ongoing signs and
symptoms at the time of informed consent

- Pleural effusion or ascites that causes respiratory compromise, grade 2 dyspnea

- History of organ allograft including corneal transplant

- Known or suspected allergy or hypersensitivity to the study drug

- Any malabsorption condition

- Any condition which makes the subject unsuitable for trial participation

- Substance abuse, medical, psychological, or social conditions that may interfere with
the subject's participation in the study.