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

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

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

Study Overview

• Status: Unknown
• Conditions: Experimental Tumor
• Intervention / Treatment: Drug: Chidamide

Detailed Description

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Li Zhang, MD; Phone Number: 86-20-87343458; Email: zhangli6@mail.sysu.edu.cn
• Study Contact Backup: Name: Wenfeng Fang, MD; Email: Fangwf@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Cancer Center of Sun Yat-Sen University (CCSU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. At least one measurable lesion according to criteria RECIST v1.1;
3. Age 18-70 years, male or female;
4. ECOG performance status 0-2;
5. Life expectancy no less than 3 months;
6. Adequate hepatic, renal and bone marrow function;
7. History of brain metastasis is eligible, but maintenance of hormone is not required;
8. Contraception during and 4 weeks after the study for patients at child bearing age;
9. Patients have signed the Informed Consent Form.

Exclusion Criteria:

1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;
2. 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;
3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
4. Patients have undergone organ transplantation;
5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
6. Patients with active hemorrhage;
7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
8. Patients with active HBV or HCV infection;
9. continuous fever within 14 days prior to enrollment;
10. Had major organ surgery within 6 weeks prior to enrollment;
11. 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);
12. Patients with mental disorders or those do not have the ability to consent;
13. Patients with drug abuse, long term alcoholism that may impact the results of the trial;
14. Patients who received treatment of HDAC inhibitors;
15. Non-appropriate patients for the trial according to the judgment of the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chidamide	Drug: Chidamide; Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate（ORR）	the total proportion of patients with complete response（CR）and partial response（PR）	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival（PFS）	Time from treatment until disease progression or death	2 years
overall survival（OS）	Time from treatment until death from any cause	2 years
Disease Control Rate （DCR）	the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）	up to 2 years
Duration of Response （DOR）	Time from first documented complete response (CR) or partial response (PR) until time of progression.	up to 2 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2018
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms; DNA Virus Infections; Tumor Virus Infections; Herpesviridae Infections; Epstein-Barr Virus Infections; Neoplasms, Experimental
• Other Study ID Numbers: CSIIT-Q08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No