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

Experimental Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03494634
• Other study ID #: CSIIT-Q08
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 4, 2018
• Last updated: April 4, 2018
• Start date: April 15, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2018
• Source: Sun Yat-sen University
• Contact: Li Zhang, MD
• Phone: 86-20-87343458
• Email: zhangli6[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Experimental Tumor

Intervention

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

Locations

Country	Name	City	State
China	Cancer Center of Sun Yat-Sen University (CCSU)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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