|Exclusion Criteria:||1) Prior therapy with an EGFR inhibitor.|
2) History of malignancy other than CRC, unless there is an exception that the malignancy has been cured and no tumor-specific treatment for the malignancy has been administered within the 5 years prior to initiation of study treatment (subjects with a history of basal cell carcinoma or benign tumor of cervix can be enrolled if diagnosis and treatment occurred < 3 years prior to randomization).
3) Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study.
4) Treatment with chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, or any other investigational anticancer agent within 4 weeks prior to start of study treatment.
5) History of cardiac disease: Congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; Active coronary artery disease (CAD); Previously diagnosed bradycardia or other cardiac arrhythmia defined as Grade 2 or higher according to NCI CTCAE, version 4.0, or uncontrolled hypertension; Myocardial infarction that occurred within 6 months prior to start of study treatment (myocardial infarction that occurred > 6 months before the start of study treatment is permitted).
6) Malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
7) Known metastatic brain or meningeal tumors, unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of first dose of study treatment, and is clinically stable (no concomitant therapy, including supportive therapy with steroids or anticonvulsant medications) with respect to the tumor at the time of first dose of study treatment.
8) Uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis.
9) Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
10) Clinically significant active infection that requires antibiotic therapy.
11) Previous administration of ARQ 197 (or other known c-MET inhibitor).
12) Substance abuse or medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical trial or evaluation of the clinical trial results.
13) Any condition that is unstable or that could jeopardize the safety of the subject and the subject's protocol compliance, including known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
14) Inability to swallow oral medications.
15) Pregnant or nursing females.