Clinical Trial: Differences Between Chidamide Taken Daily and Twice a Week in Therapeutic Effect，Pharmacokinetics, Pharmacodynamics and EB Virus Activation

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

Official Title: Research About the Differences Between Chidamide Taken Daily and Twice a Week in Pharmacokinetics

Brief Summary:

  1. To compare the therapeutic effects, safety and the corresponding pharmacokinetics and pharmacodynamics between two different method of drug administration: 10mg, daily and 30mg/d, twice every week, and find out the more effect way of Chidamide administration.
  2. To examine whether Chidamide could activate EB virus, and whether the above two different ways of administration are different in EB virus activation.

Detailed Summary:

Currently, Chidamide is taken twice a week, this comes from cell experiment and phase I clinical trial, which showed that the de-acetylation effect of Chidamide could last for 72 hours after administration. However, daily administration of Chidamide may create a more steady Chidamide concentration, thus improve the de-acetylation effect of Chidamide, so it's necessary to compare the two different ways of administration.

Current study showed that Romidepsin, a HDACI, could activate EBV during the treatment of NKTCL, whether Chidamide, as a novel HDACI, could activate EBV is still not clear, so this problem is worth to be accessed.


Sponsor: Huiqiang Huang

Current Primary Outcome:

  • Overall Response Rate (ORR) [ Time Frame: through study completion, an average of 30 months ]
  • Duration of Response (DOR) [ Time Frame: through study completion, an average of 30 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: through study completion, an average of 30 months ]
  • Overall Survival (OS) [ Time Frame: through study completion, an average of 30 months ]
  • EBV-DNA [ Time Frame: through study completion, an average of 30 months ]
  • EBV-antibodies [ Time Frame: through study completion, an average of 30 months ]
  • white blood cell count [ Time Frame: every week 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 30 months ]
  • red blood cell count [ Time Frame: every week 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 30 months ]
  • blood Hb level [ Time Frame: every week 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 30 months ]
  • blood platelet count [ Time Frame: every week 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 30 months ]
  • vital signs [ Time Frame: every week 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 30 months ]
  • Serum alanine aminotransferase 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 30 months ]
  • Serum aspartate transaminase 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 30 months ]
  • Serum total bilirubin 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 30 months ]
  • Serum direct bilirubin 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 30 months ]
  • Serum indirect bilirubin 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 30 months ]
  • Serum glutamyltranspeptidase 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 30 months ]
  • Serum albumin 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 30 months ]
  • Serum ureal nitrogen 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 30 months ]
  • Serum creatinin 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 30 months ]
  • fasting blood glucose 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 30 months ]
  • blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+） [ 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 30 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 30 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 30 months ]


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: August 20, 2016
Date Started: September 2016
Date Completion: September 2019
Last Updated: August 22, 2016
Last Verified: August 2016