An Uncontrolled, Open-label, Phase II Study in Subjects With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First Line Chemotherapy With mFOLFOX6 (Oxaliplatin/ Folinic Acid/5-fluorouracil [5-FU]) in Combination With Regorafenib

Inclusion Criteria:

- Male or female subjects aged ≥ 18 years

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

- Suitable to receive mFOLFOX6 regimen as first line metastatic treatment

- At least 1 measurable lesion as per RECIST version 1.1

- Unresectable or unlikely becoming resectable metastatic disease

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy of at least 3 months

- Adequate bone marrow, liver, and renal function

Exclusion Criteria:

- Prior systemic anticancer therapy for metastatic colorectal cancer (CRC). Adjuvant
chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended >
6 months before screening and recurrent disease was documented.

- Prior treatment with antivascular endothelial growth factor (anti-VEGF) agents and
any signal transduction inhibitors (STIs)

- Uncontrolled hypertension

- Subjects with symptoms, signs, or history of brain metastases

- Any hemorrhage or bleeding event ≥ Common Terminology Criteria for Adverse Events
(CTCAE) Grade 3 within 4 weeks of start of study treatment

- Sensory neuropathy (> CTCAE Grade 1), unresolved toxicity > CTCAE Grade 1 attributed
to any prior therapy/procedure excluding alopecia