Back to resultsChidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Primary Purpose
Experimental Tumor
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Experimental Tumor
Eligibility Criteria
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.
Sites / Locations
- Cancer Center of Sun Yat-Sen University (CCSU)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chidamide
Arm Description
Outcomes
Primary Outcome Measures
objective response rate（ORR）
the total proportion of patients with complete response（CR）and partial response（PR）
Secondary Outcome Measures
Disease Control Rate （DCR）
the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）
Duration of Response （DOR）
Time from first documented complete response (CR) or partial response (PR) until time of progression.
progression-free survival（PFS）
Time from treatment until disease progression or death
overall survival（OS）
Time from treatment until death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03494634
Brief Title
Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Official Title
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2018 (Anticipated)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Experimental Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chidamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
Primary Outcome Measure Information:
Title
objective response rate（ORR）
Description
the total proportion of patients with complete response（CR）and partial response（PR）
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Disease Control Rate （DCR）
Description
the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）
Time Frame
up to 2 years
Title
Duration of Response （DOR）
Description
Time from first documented complete response (CR) or partial response (PR) until time of progression.
Time Frame
up to 2 years
Title
progression-free survival（PFS）
Description
Time from treatment until disease progression or death
Time Frame
2 years
Title
overall survival（OS）
Description
Time from treatment until death from any cause
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhang, MD
Phone
86-20-87343458
Email
zhangli6@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wenfeng Fang, MD
Email
Fangwf@sysucc.org.cn
Facility Information:
Facility Name
Cancer Center of Sun Yat-Sen University (CCSU)
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
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