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Brief Title: Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
Official Title: A Phase 2, Multicenter, International, Single Arm Study To Assess The Safety And Efficacy Of Single Agent Cc-486 (Oral Azacitidine) In Previously Treated Subjects With Locally Advanced Or Metastatic Nasopharyngeal Carcinoma
Study ID: NCT02269943
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Columbia Comprehensive Cancer Care Clinic, Jefferson City, Missouri, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
McGill University, Montreal, Quebec, Canada
Institut Hospitalier Franco-Britannique, Levallois-Perret, , France
Institut Curie, Paris, , France
Institut Gustave Roussy, Villejuif Cedex, , France
University General Hospital of Heraklion, Heraklion, , Greece
Thermi Clinic, Thessaloniki, , Greece
Istituto Nazionale Dei Tumori, Milano, , Italy
National Cancer Center, Singapore, , Singapore
Singapore Oncology Consultants, Singapore, , Singapore
Johns Hopkins Singapore International Medical Centre, Singapore, , Singapore
Instituto Catalan de Oncologia-Hospital Duran, Barcelona, , Spain
Hospital Universitario Madrid Sanchinarro, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital, Niao-Sung Hsiang Kaohsiung County, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Hopital Abderrahman Mami de Pneumo-Phtisiologie de l'Ariana, Ariana, , Tunisia
Institut Salah Azaiez, Bab Saadoun, , Tunisia
Hospital Habib Bourguiba, Sfax, , Tunisia
Name: Abderahim (Rahim) Fandi, MD, PhD
Affiliation: Celgene
Role: STUDY_DIRECTOR