Experimental TumorPhase 2NCT03494634
Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
A Phase 2 study testing Chidamide in people with Experimental Tumor, run by Sun Yat-sen University at 1 site in China.
Trial summary
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Experimental Tumor
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2018to 30 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Wenfeng Fang, MD contact
About this study
Official title: Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors
Read the 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.
- Conditions
- Experimental Tumor
- Being tested
- Chidamide
- Medical subject headings
- Neoplasms, Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide | Experimental | Not described Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate（ORR）
the total proportion of patients with complete response（CR）and partial response（PR）
Measured: up to 2 years
Secondary outcomes (4)
Disease Control Rate （DCR）
the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）
Measured: up to 2 years
Duration of Response （DOR）
Time from first documented complete response (CR) or partial response (PR) until time of progression.
Measured: up to 2 years
progression-free survival（PFS）
Time from treatment until disease progression or death
Measured: 2 years
overall survival（OS）
Time from treatment until death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start15 Apr 2018 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experimental TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494634
- Sponsor's protocol ID
- CSIIT-Q08
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
- ClinicalTrials.gov ID
- NCT03494634
- Acronym / sponsor ID
- CSIIT-Q08
- Conditions
- Experimental Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide | Experimental | Drug: Chidamide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChidamideChidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks. | Drug | Chidamide |
Primary outcome
objective response rate（ORR）
Time frame: up to 2 years
the total proportion of patients with complete response（CR）and partial response（PR）
4 secondary outcomes
Disease Control Rate （DCR）
Time frame: up to 2 years
Duration of Response （DOR）
Time frame: up to 2 years
progression-free survival（PFS）
Time frame: 2 years
overall survival（OS）
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenfeng Fang, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide in people with Experimental Tumor, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, MD (86-20-87343458, zhangli6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate（ORR） (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.