Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects Previously Untreated for Stage IV Disease

Inclusion Criteria:

- Histological confirmation of adenocarcinoma of the colon or rectum

- Tumor tissue sample available for KRAS and BRAF assessment

- Measurable metastatic Stage IV disease including at least one measurable lesion that
has not previously been radiated

- No prior chemotherapy for metastatic CRC

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

- Life expectancy of at least 12 weeks

- Adequate bone marrow, liver, and renal function; adequate clotting parameters

Exclusion Criteria:

- Prior treatment with sorafenib

- Clinical or radiographic evidence of brain metastasis

- Major surgery, surgical biopsy, or significant traumatic injury within 28 days of
randomization; evidence or history of bleeding diathesis or coagulopathy

- Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth
factor use within 28 days before randomization

- Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before
randomization

- Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within
28 days before randomization

- Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of
thrombosis due to placement of a semi-permanent central venous port for
administration of chemotherapy is allowed. The use of coumadin and related compounds
is excluded.)

- Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure >
100 mmHg on repeated measurement) despite optimal medical management

- Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident,
including transient ischemic attacks) within 6 months before randomization

- Active cardiac disease including:

- Congestive heart failure

- Unstable angina or myocardial infarction within the 6 months before
randomization

- Cardiac ventricular arrhythmias requiring antiarrhythmic treatment

- Peripheral neuropathy > Grade 1 (CTCAE)

- Known HIV infection or chronic hepatitis B or C infection

- Any active infection >/= Grade 2 (CTCAE)

- Any medical, psychological, or social condition that may interfere with the subject's
participation in the study or evaluation of the study results

- Use of any investigational drug within 28 days or 5 half-lives of that drug,
whichever is longer, before randomization

- Subjects with metastatic CRC who are currently candidates for surgery with curative
intent