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

Celgene Corporation0 个研究点目标入组 55 人开始时间: 2015年5月15日最近更新: 2018年2月12日

适应症

试验速览

暂无简介。

•- 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 to 2 previous regimens.
•- Patient has received a platinum containing regimen.
•- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
•- Radiographically-documented measurable disease.
•- Adequate organ and bone marrow functions.
•- Willingness to follow pregnancy precautions.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 47
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•- 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 nonmelanomatous 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, or any other hypomethylating agent.
•- Impaired ability to swallow oral medication.
•- Persistent diarrhea or malabsorption.
•- 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.
•- 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.

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