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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Disease control rate

Secondary Outcome

 Toxicities

Condition

Adenocystic Carcinoma

Intervention

Chidamide

Study Arms / Comparison Groups

 Chidamide

Description:  Patients of advanced cephalic and cervical adenocystic carcinoma are given Chidamide 30mg,biw, then the efficacy and safety will be accessed.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

30

Start Date

November 2016

Completion Date

June 2020

Primary Completion Date

June 2020

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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Mei Dong, Doctor, （+86）10-87788130, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT02883374

Organization ID

CancerIHCAMS16-053/1132

Responsible Party

Sponsor-Investigator

Study Sponsor

Dong mei

Study Sponsor

Mei Dong, Doctor, Principal Investigator, Cancer Hospital, Chinese ACademy of Medical Science

Verification Date

August 2017