safety and efficacy of cc-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of cc-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. participants will be enrolled according to a simon two-stage design; if the predefined activity is met (\>4 responses \[complete response; partial response {cr/pr}\] out of the first 17 evaluable participants based on independent radiological assessment), then the study will continue to enroll an additional 34 participants. if 4 or less responses out of 17 are observed, then the study enrollment will be stopped.


Eligibility criteria:
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.

Keywords: metastatic nasopharyngeal carcinoma oral azacitidine oral aza cc-486 metastatic recurrent nasopharyngeal carcinoma nasal solid tumors locally advanced rare head and neck cancer nasopharynx single chemotherapy agent epstein-barr virus (ebv) + nasopharyngeal carcinoma ebv-dn celgene sponsor-study oral chemotherapy phase 2 oral vidaza ebv promoter methylation hypomethylation tumor infiltrating lymphocytes (tils) ebv gene expression neoplasms