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

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.