SGI-110 in Combination With Carboplatin in Ovarian Cancer

Inclusion Criteria:

1. Patients who are women 18 years of age or older.

2. Patients who have histologically or cytologically confirmed recurrent high-grade
serous epithelial ovarian cancer (Grade 2 or 3), primary peritoneal carcinomatosis or
fallopian tube cancer.

3. Patients who have platinum-resistant disease (defined as having relapsed within 6
months of her last platinum-containing regimen). There is no limit on the number of
prior treatment regimens in Part 1. In Part 2, patients may have had no more than 3
prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy.

4. Patients must have had prior paclitaxel treatment.

5. Patients who have measurable disease according to RECIST v1.1 or detectable disease.

6. Patients with ECOG performance status of 0 or 1.

7. Patients with acceptable organ function.

8. Patients must be at least 3 weeks from last chemotherapy.

Exclusion Criteria:

1. Patients who have hypersensitivity to SGI-110 and/or carboplatin or other components
of these drug products.

2. Patients who have received prior therapy with any hypomethylating agents.

3. Patients who are refractory to platinum treatment i.e., progressed while on platinum
treatment.

4. Patients with abnormal left ventricular ejection fraction.

5. Patients with Grade 2 or greater neuropathy.

6. Patients with known brain metastases.

7. Patients with known history of HIV, HCV or HBV.