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