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

NCT02883374 | Unknown Phase 2 DMC

• 1 other identifier: CancerIHCAMS16-053/1132
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocystic Carcinoma

Keywords

cephalic and cervical adenocystic Carcinoma; Chidamide

Outcome Measures

Primary Outcomes (1)

• Disease control rate

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

  through study completion, an average of 33 months

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Chidamide

EXPERIMENTAL

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

Drug: Chidamide

Interventions

Chidamide DRUG

Also known as: epidaza

Chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong mei: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Mei Dong, Doctor

  Cancer Hospital Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Dong, Doctor

CONTACT

（+86）10-87788130; Dongmei030224@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

CN (1)