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

Primary Purpose

Adenocystic Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
Dong mei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocystic Carcinoma focused on measuring cephalic and cervical adenocystic Carcinoma, Chidamide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide

Arm Description

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

Outcomes

Primary Outcome Measures

Disease control rate
percentage of patients who get complete remission, partial remission and stable disease.

Secondary Outcome Measures

Toxicities
Hematologic toxicities and non-hematologic toxicities including nausea,vomiting,liver, heart and other organ disfunctions.
QOL score
improvement of patients' feeling and quality of daily life

Full Information

First Posted
August 25, 2016
Last Updated
August 30, 2017
Sponsor
Dong mei
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1. Study Identification

Unique Protocol Identification Number
NCT02883374
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dong mei

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocystic Carcinoma
Keywords
cephalic and cervical adenocystic Carcinoma, Chidamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide
Arm Type
Experimental
Arm Description
Patients of advanced cephalic and cervical adenocystic carcinoma are given Chidamide 30mg,biw, then the efficacy and safety will be accessed.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
epidaza
Primary Outcome Measure Information:
Title
Disease control rate
Description
percentage of patients who get complete remission, partial remission and stable disease.
Time Frame
through study completion, an average of 33 months
Secondary Outcome Measure Information:
Title
Toxicities
Description
Hematologic toxicities and non-hematologic toxicities including nausea,vomiting,liver, heart and other organ disfunctions.
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
Title
QOL score
Description
improvement of patients' feeling and quality of daily life
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of advanced cephalic and cervical adenocystic carcinoma with pathological and imaging evidences, with local relapse or metastasis or refractory towards treatment. Age 18-75, male or female, expected survival≥ 3 months. ECOG 0-2. With at least one evaluable disease focus. 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: History of HDACI treatment. Women during pregnancy or lactation. 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) Patients with central nervous system defects or mental disorders. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Dong, Doctor
Phone
(+86)10-87788130
Email
Dongmei030224@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Dong, Doctor
Organizational Affiliation
Cancer Hospital, Chinese ACademy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Dong, Doctor
Phone
13811929322
Email
dongmei030224@163.com
First Name & Middle Initial & Last Name & Degree
Mei Dong, Doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data of the trial would be accessable on the corresponding website after the trial has been finished.

Learn more about this trial

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

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