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

NCT ID: NCT02883374

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Adenocystic Carcinoma

Keywords

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cephalic and cervical adenocystic Carcinoma Chidamide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chidamide

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

Group Type EXPERIMENTAL

Chidamide

Intervention Type DRUG

Interventions

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Chidamide

Intervention Type DRUG

Other Intervention Names

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epidaza

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong mei

OTHER

Sponsor Role lead

Responsible Party

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Dong mei

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mei Dong, Doctor

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science

Locations

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Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mei Dong, Doctor

Role: CONTACT

Phone: （+86）10-87788130

Email: [email protected]

Facility Contacts

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Mei Dong, Doctor

Role: primary

Other Identifiers

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CancerIHCAMS16-053/1132

Identifier Type: -

Identifier Source: org_study_id