A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer

Inclusion Criteria:

1. For phase I, any solid tumors, including lymphoma, that progressed or were stable as
best response on at least one previous therapy and are evaluable.

2. For phase II, pathologically confirmed breast cancer, measurable disease, no prior
treatments for recurrent or metastatic breast cancer.

3. Her-2/neu negative (Phase II)

4. Negative pregnancy test for female subjects

5. Women of childbearing potential should be advised to avoid becoming pregnant and men
should be advised to not father a child while receiving treatment with azacitidine or
nab-paclitaxel. investigator.

6. Male or female for phase I and female for phase II, >19 years of age and any race.

Exclusion Criteria:

1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of
treatment day 1

2. Known brain or leptomeningeal metastases

3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day
1) (phase II)

4. Active infection requiring antibiotic therapy

5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane

6. Grade 2 or greater motor or sensory neuropathy

7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II
portion)

8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients
who have had a myocardial infarction or cardiac surgery should be at least 6 months
from the event and free of active symptoms.

9. Known or suspected hypersensitivity to azacitidine or mannitol

10. Pregnant or breast feeding

11. Patients with advanced malignant hepatic tumors

12. Malignancy other than breast carcinoma (phase II)

13. Known HIV infection or chronic hepatitis B or C