NCT03494634UnknownPhase 2
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Sun Yat-sen University1 site in 1 country66 target enrollmentStarted: April 15, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- objective response rate（ORR）
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •At least one measurable lesion according to criteria RECIST v1.1;
- •Age 18-70 years, male or female;
- •ECOG performance status 0-2;
- •Life expectancy no less than 3 months;
- •Adequate hepatic, renal and bone marrow function;
- •History of brain metastasis is eligible, but maintenance of hormone is not required;
- •Contraception during and 4 weeks after the study for patients at child bearing age;
- •Patients have signed the Informed Consent Form.
Exclusion Criteria
- •Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;
- •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;
- •pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
- •Patients have undergone organ transplantation;
- •Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
- •Patients with active hemorrhage;
- •Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
- •Patients with active HBV or HCV infection;
- •continuous fever within 14 days prior to enrollment;
- •Had major organ surgery within 6 weeks prior to enrollment;
- •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);
- •Patients with mental disorders or those do not have the ability to consent;
- •Patients with drug abuse, long term alcoholism that may impact the results of the trial;
- •Patients who received treatment of HDAC inhibitors;
- •Non-appropriate patients for the trial according to the judgment of the investigators.
Arms & Interventions
Chidamide
Experimental
Intervention: Chidamide (Drug)
Outcomes
Primary Outcomes
objective response rate（ORR）
Time Frame: up to 2 years
the total proportion of patients with complete response（CR）and partial response（PR）
Secondary Outcomes
- Duration of Response （DOR）(up to 2 years)
- progression-free survival（PFS）(2 years)
- overall survival（OS）(2 years)
- Disease Control Rate （DCR）(up to 2 years)
Investigators
Li Zhang
director
Sun Yat-sen University
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 2
Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular LymphomaExperimentalNCT03410004Chinese Academy of Medical Sciences40
Recruiting
Phase 2
Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell LymphomaT Cell LymphomaNCT05367856Ruijin Hospital23
Unknown
Phase 2
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHLRelapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)NCT03245905Sun Yat-sen University100
Active, not recruiting
Phase 2
A Clinical Study Assessing the Efficacy of Chidamide for CD30-positive Peripheral T-cell Lymphoma (PTCL).Peripheral T Cell LymphomaNCT06550336The First Hospital of Jilin University35
Completed
Phase 3
Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast CancerBreast CancerNCT02482753Chipscreen Biosciences, Ltd.365