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

Phase 2

• Conditions: Adenocystic Carcinoma
• Interventions: Drug: Chidamide

• Registration Number: NCT02883374
• Lead Sponsor: Dong mei

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 available

Study Timeline

• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-08-30
• Study Start: 2016-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Disease control rate	through study completion, an average of 33 months	percentage of patients who get complete remission, partial remission and stable disease.

Secondary Outcome Measures

Name	Time	Method
QOL score	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
Toxicities	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.

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China