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Spots Global Cancer Trial Database for Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma

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Trial Identification

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

Interventions

CC-486

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Abderahim (Rahim) Fandi, MD, PhD

Affiliation: Celgene

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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