Overview
Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Status:
Unknown status
Unknown status
Trial end date:
2020-09-30
2020-09-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid TumorsPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sun Yat-sen University
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.