SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

1. 18 years of age or older

2. Histological or cytological confirmed hepatocellular carcinoma with advanced stage
disease

3. Received prior sorafenib treatment, and showed evidence of disease progression, which
is defined as Investigator verified radiologic progression, or intolerance of prior
systemic therapy, which is defined as having had clinically significant adverse
events that persisted despite one or more dose reductions or interruptions

4. ECOG performance status of 0-1

5. Acceptable organ function

6. Signed an approved informed consent

Exclusion Criteria:

1. Known hypersensitivity to SGI-110

2. Adequate washout of prior radiation, chemotherapy or other locoregional therapy

3. Abnormal left ventricular ejection fraction

4. Uncontrolled ischemic heart disease or a history of congestive cardiac failure

5. Known brain metastases

6. Clinically evident ascites

7. Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points

8. Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, non-metastatic prostate cancer with normal PSA or
other cancer from which the subject has been disease free for at least three years

9. Known history of human immunodeficiency virus (HIV)