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

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ClinicalTrials.gov Identifier: NCT02883374
Recruitment Status : Unknown
Verified August 2017 by Dong mei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : August 30, 2016
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Dong mei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 25, 2016
First Posted Date  ICMJE August 30, 2016
Last Update Posted Date August 31, 2017
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
Disease control rate [ Time Frame: through study completion, an average of 33 months ]
percentage of patients who get complete remission, partial remission and stable disease.
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
  • Toxicities [ 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 ]
    Hematologic toxicities and non-hematologic toxicities including nausea,vomiting,liver, heart and other organ disfunctions.
  • QOL score [ 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 ]
    improvement of patients' feeling and quality of daily life
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocystic Carcinoma
Intervention  ICMJE Drug: Chidamide
Other Name: epidaza
Study Arms  ICMJE Experimental: Chidamide
Patients of advanced cephalic and cervical adenocystic carcinoma are given Chidamide 30mg,biw, then the efficacy and safety will be accessed.
Intervention: Drug: Chidamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 29, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients of advanced cephalic and cervical adenocystic carcinoma with pathological and imaging evidences, with local relapse or metastasis or refractory towards treatment.
  2. Age 18-75, male or female, expected survival≥ 3 months.
  3. ECOG 0-2.
  4. With at least one evaluable disease focus.
  5. Organ functions should fit the following:

Liver: Total bilirubin ≤ 1.5 times of the normal maximum, ALT and AST≤ 2.5 times of the normal maximum. (ALT/AST≤ 5 times of the normal maximum for patients with infiltrative liver disease) Kidney: Serum creatinine ˂ 1.5 folds of the normal maximum; creatinine clearance rate ≥50ml/min (calculated by Cockroft-Gault10 formula)

Exclusion Criteria:

  1. History of HDACI treatment.
  2. Women during pregnancy or lactation.
  3. Patients with a second primary tumor ( this does not include non-melanoma skin cancer received systemic treatment, cured cervical carcinoma in situ of the uterus, or other tumors that have been cured with disease free survival˃ 5 years)
  4. Patients with central nervous system defects or mental disorders.
  5. Other diseases or contraindications: History of heart disease within 6 months prior to inclusion, including NYHA III—IV heart failure after treatment, coronary heart disease, angina pectoris, myocardial infarction, degree II or III atrioventricular block, severe arrhythmias that need medical treatment, uncontrolled hypertension; liver cirrhosis (Child-Pugh B or C); active infection that has not been controlled, and other conditions that may make the patient unable to complete the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02883374
Other Study ID Numbers  ICMJE CancerIHCAMS16-053/1132
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The data of the trial would be accessable on the corresponding website after the trial has been finished.
Responsible Party Dong mei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Dong mei
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mei Dong, Doctor Cancer Hospital, Chinese ACademy of Medical Science
PRS Account Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP