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:
- 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.
- 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