Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors

NCT03494634 | Unknown Phase 2

• 1 other identifier: CSIIT-Q08
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors

Conditions

Experimental Tumor

Outcome Measures

Primary Outcomes (1)

• objective response rate（ORR）

  the total proportion of patients with complete response（CR）and partial response（PR）

  up to 2 years

Secondary Outcomes (4)

• Disease Control Rate （DCR）

  up to 2 years

• Duration of Response （DOR）

  up to 2 years

• progression-free survival（PFS）

  2 years

• overall survival（OS）

  2 years

Study Arms (1)

Chidamide

EXPERIMENTAL

Drug: Chidamide

Interventions

Chidamide DRUG

Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.

Chidamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors, including nasopharyngeal carcinoma and other solid tumors (Lymphoma excluded). Patients must have failed at least one systemic treatment and been refractory to platinum-containing regimens;
• At least one measurable lesion according to criteria RECIST v1.1;
• Age 18-70 years, male or female;
• ECOG performance status 0-2;
• Life expectancy no less than 3 months;
• Adequate hepatic, renal and bone marrow function;
• History of brain metastasis is eligible, but maintenance of hormone is not required;
• Contraception during and 4 weeks after the study for patients at child bearing age;
• Patients have signed the Informed Consent Form.

You may not qualify if:

• Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;
• QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
• pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
• Patients have undergone organ transplantation;
• Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
• Patients with active hemorrhage;
• Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
• Patients with active HBV or HCV infection;
• continuous fever within 14 days prior to enrollment;
• Had major organ surgery within 6 weeks prior to enrollment;
• Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum);
• Patients with mental disorders or those do not have the ability to consent;
• Patients with drug abuse, long term alcoholism that may impact the results of the trial;
• Patients who received treatment of HDAC inhibitors;
• Non-appropriate patients for the trial according to the judgment of the investigators.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun Yat-Sen University (CCSU)

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Neoplasms, Experimental

Interventions

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

Condition Hierarchy (Ancestors)

Neoplasms

Central Study Contacts

Li Zhang, MD

CONTACT

86-20-87343458; zhangli6@mail.sysu.edu.cn

Wenfeng Fang, MD

CONTACT

Fangwf@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: April 15, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2020
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)