Clinical Trial: Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety

Brief Summary: The purpose of this trial is to evaluate the efficiency and safety of Chidamide in advanced cephalic and cervical adenoid cystic carcinoma. Chidamide is given to patients with advanced cephalic and cervical adenoid cystic carcinoma with the dosage of 30mg,twice a week, then overall survival, event-free survival are accessed for efficiency, and laboratory tests about the function of vital organs are accessed for safety.

Detailed Summary:
Sponsor: Dong mei

Current Primary Outcome:

  • Objective Remission Rate [ Time Frame: through study completion, an average of 33 months ]
  • Duration of remission [ Time Frame: through study completion, an average of 33 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • white blood cell count [ Time Frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • red blood cell count [ Time Frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • blood Hb level [ Time Frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • blood platelet count [ Time Frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • vital signs [ Time Frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum alanine aminotransferase level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum aspartate aminotransferase level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum total bilirubin level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum direct bilirubin level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum indirect bilirubin level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum glutamyltranspeptidase level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum albumin level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum ureal nitrogen level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • Serum creatinin level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • fasting blood glucose level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+） [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • blood LDH level [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]
  • QTc from ECG [ Time Frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months ]


Original Secondary Outcome: Same as current

Information By: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Dates:
Date Received: August 25, 2016
Date Started: September 2016
Date Completion: June 2020
Last Updated: August 29, 2016
Last Verified: August 2016