Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma

Inclusion Criteria:

- Age = or > 18 years Histological or cytological diagnosis of undifferentiated or
poorly differentiated nasopharyngeal carcinoma that is locally advanced or metastatic.

- Disease progression either clinically or radiographically after 1-2 previous regimens.

- Patient has received a platinum containing regimen. Eastern Cooperative Oncology Group
(ECOG) performance status 0-2. Radiographically-documented measureable disease.

- Adequate organ and bone marrow functions.

- Willingness to follow pregnancy precautions.

Exclusion Criteria:

- History of, or current brain metastasis. Any other malignancy within 5 years prior to
randomization with the exception of adequately treated in situ carcinoma of the
cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have
been completed 6 months prior to enrollment), in situ squamous cell carcinoma of the
breast, or incidental prostate cancer.

- Previous treatment with azacitidine (any formulation), decitabine, any other
hypomethylating agent.

- History of gastrointestinal disorder or defect. Impaired ability to swallow oral
medication. Persistent diarrhea or malabsorption.

- Active cardiac disease and human immunodeficiency virus (HIV) infection

- Active bleeding; pathological condition that carries a high risk of bleeding; risk of
pseudoaneurysm of the internal carotid artery and carotid blowout syndrome.

- Major surgery within 14 days prior to starting Investigational Product or has not
recovered from major side effects.

- Another investigational therapy within 28 days or 5 half lives of
randomization/enrollment, whichever is shorter.

- Patient has not recovered from the acute toxic effects of prior anticancer therapy,
radiation, or major surgery/significant trauma.

- Radiotherapy < or = 4 weeks or limited field radiation for palliation < or = 2 weeks
prior to starting with the investigational product.

- Pregnancy/Breast feeding

- Any condition that places the patient at unacceptable risk if he/she were to
participate in the study or that confounds the ability to interpret data from the
study.