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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03494634
Other study ID # CSIIT-Q08
Secondary ID
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
Health authority
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:

Chidamideļ¼Œa 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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03611231 - Chidamide Maintenance After Autologous Hematopoietic Stem Cell Transplantation for Relapsed, Refractory or High-risk Lymphoma Phase 2
Recruiting NCT03617432 - Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients Phase 2