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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:February 13, 2015
End Date:April 20, 2017

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
6
sites
1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Jefferson City, Missouri 65109
?
mi
from
Jefferson City, MO
Click here to add this to my saved trials
?
mi
from
Toronto,
Click here to add this to my saved trials