Status:
COMPLETED
Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
Lead Sponsor:
Celgene
Conditions:
Nasopharyngeal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02269943
Start Date
February 13 2015
End Date
April 20 2017
Last Update
December 12 2018
Active Locations (25)
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1
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65101