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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 : 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

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.

Condition or disease Intervention/treatment Phase
Adenocystic Carcinoma Drug: Chidamide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety
Study Start Date : November 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chidamide
Patients of advanced cephalic and cervical adenocystic carcinoma are given Chidamide 30mg,biw, then the efficacy and safety will be accessed.
Drug: Chidamide
Other Name: epidaza




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883374


Contacts
Contact: Mei Dong, Doctor (+86)10-87788130 Dongmei030224@163.com

Locations
China, Beijing
Cancer Hospital, Chinese Academy of Medical Science Recruiting
Beijing, Beijing, China, 100021
Contact: Mei Dong, Doctor    13811929322    dongmei030224@163.com   
Principal Investigator: Mei Dong, Doctor         
Sponsors and Collaborators
Dong mei
Investigators
Principal Investigator: Mei Dong, Doctor Cancer Hospital, Chinese ACademy of Medical Science

Responsible Party: Dong mei, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02883374     History of Changes
Other Study ID Numbers: CancerIHCAMS16-053/1132
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (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.

Keywords provided by Dong mei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
cephalic and cervical adenocystic Carcinoma
Chidamide

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma