Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
NCT00367718 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2020-05-18
Summary
This study seeks to test the Efficacy in terms of rates of disease response in metastatic nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between 15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral load and molecular characterization of EBV in plasma.
Conditions
- Nasopharyngeal Carcinoma
Interventions
- DRUG
-
velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule.
Sponsors & Collaborators
-
Janssen-Cilag Ltd.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Wen-son Hsieh, M.D. · Johns Hopkins Singapore-International Medical Center
-
Brigette Ma, M.D. · Chinese University of Hong Kong
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- China
- Singapore
Study Locations
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