Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Neoplasms
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
Intervention: CC-486
Intervention MeSH terms: Azacitidine; Cc-486
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.