Overview

This trial is active, not recruiting.

Condition nasopharyngeal neoplasms
Treatment cc-486
Phase phase 2
Sponsor Celgene Corporation
Start date February 2015
End date December 2016
Trial size 36 participants
Trial identifier NCT02269943, 2014-001745-25, CC-486-NPC-001

Summary

The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated subjects with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. Approximately 51-55 subjects 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 subjects based on independent radiological assessment), then the study will continue to enroll an additional 34 subjects. If < or = 4 responses out of 17 are observed, then the study enrollment will be stopped.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
CC-486 will be administered orally every day on Days 1-14 of a 21 day cycle at a dose of 300mg. The first 6 evaluable for safety subjects of Asian-Pacific ethnicity, a starting dose of 200 mg will be tested. If there are no safety concerns, the 300 mg dose will be administered to all subsequent subjects of Asian-Pacific ethnicity.
cc-486 oral azacitidine

Primary Outcomes

Measure
Overall response rate
time frame: Up to approximately 2 years
Progression-free survival
time frame: Up to approximately 1 year

Secondary Outcomes

Measure
Overall survival
time frame: Approximately 2 years
Safety
time frame: Approximately 1 year
Pharmacokinetics - AUC
time frame: Days 1 and 14
Pharmacokinetics - Cmax
time frame: Days 1 and 14
Pharmacokinetics - t1/2
time frame: Days 1 and 14
Pharmacokinetics - Tmax
time frame: Days 1 and 14
Pharmacokinetics - CL/F
time frame: Days 1 and 14
Pharmacokinetics - Vz/F
time frame: Days 1 and 14
Disease Control Rate
time frame: Up to 2 Yrs

Eligibility Criteria

Male or female participants at least 18 years old.

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 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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.
Location data was received from the National Cancer Institute and was last updated in July 2016.