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

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

Tracking Information

• First Submitted Date: August 25, 2016
• First Posted Date: August 30, 2016
• Last Update Posted Date: August 31, 2017
• Study Start Date: November 2016
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety
• 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Adenocystic Carcinoma

Intervention

Drug: Chidamide

Other Name: epidaza

Study Arms

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 29, 2016): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2020
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02883374
• Other Study ID Numbers: CancerIHCAMS16-053/1132
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Dong mei
• Collaborators: Not Provided

Investigators

• 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