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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494634
Recruitment Status : Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Brief Summary:
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors

Condition or disease Intervention/treatment Phase
Experimental Tumor Drug: Chidamide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Estimated Study Start Date : April 15, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: Chidamide Drug: Chidamide
Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.




Primary Outcome Measures :
  1. objective response rate(ORR) [ Time Frame: up to 2 years ]
    the total proportion of patients with complete response(CR)and partial response(PR)


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: up to 2 years ]
    the total proportion of patients with complete response(CR), partial response(PR)and Stable Disease(SD)

  2. Duration of Response (DOR) [ Time Frame: up to 2 years ]
    Time from first documented complete response (CR) or partial response (PR) until time of progression.

  3. progression-free survival(PFS) [ Time Frame: 2 years ]
    Time from treatment until disease progression or death

  4. overall survival(OS) [ Time Frame: 2 years ]
    Time from treatment until death from any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494634


Contacts
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Contact: Li Zhang, MD 86-20-87343458 zhangli6@mail.sysu.edu.cn
Contact: Wenfeng Fang, MD Fangwf@sysucc.org.cn

Locations
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China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
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Responsible Party: Li Zhang, director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03494634    
Other Study ID Numbers: CSIIT-Q08
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Experimental
Neoplasms