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

Completed · Phase 2

Conditions studied: Nasopharyngeal Neoplasms

In brief

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.

Key facts

Study ID

NCT02269943

Run by

Celgene

People needed

36

Starts

2015-02-13

Expected to finish

2017-04-20

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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, France
• University General Hospital of Heraklion — Heraklion, Greece
• Thermi Clinic — Thessaloniki, Greece
• Istituto Nazionale Dei Tumori — Milan, 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 — Aryanah, Tunisia
• Institut Salah Azaiez — Bab Saadoun, Tunisia
• Hospital Habib Bourguiba — Sfax, Tunisia

Full record on ClinicalTrials.gov

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