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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Experimental Tumor

Treatments: Drug: Chidamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03494634

CSIIT-Q08

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Chidamide

Experimental group

Treatment:

Drug: Chidamide