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

Phase 2

• Conditions: Experimental Tumor
• Interventions: Drug: Chidamide

• Registration Number: NCT03494634
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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 Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-04
• Last Update Submitted: 2018-04-04
• Study First Posted: 2018-04-11
• Last Update Posted: 2018-04-11
• Study Start: 2018-04-15
• Primary Completion: 2019-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chidamide	Chidamide	-

Primary Outcome Measures

Name	Time	Method
objective response rate（ORR）	up to 2 years	the total proportion of patients with complete response（CR）and partial response（PR）

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Center of Sun Yat-Sen University (CCSU); 🇨🇳 Guangzhou, Guangdong, China