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

NCT ID: NCT03494634

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2020-09-30

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.

Conditions

Experimental Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

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

Interventions

Chidamide

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Center of Sun Yat-Sen University (CCSU)

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Li Zhang, MD

Role: CONTACT

zhangli6@mail.sysu.edu.cn

86-20-87343458

Wenfeng Fang, MD

Role: CONTACT

Fangwf@sysucc.org.cn

Other Identifiers

CSIIT-Q08

Identifier Type: -

Identifier Source: org_study_id