Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

30 mg tucidinostat was given orally(as six 5 mg tablets per day) twice a week (either, Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday) for 4 consecutive weeks in a 4-week cycle.The endocrine drugs combined with tucidinostat were given based on previous treatment.Patients received tucidinostat-based treatment until disease progression or intolerable adverse events.

Tucidinostat in combination with endocrine drugs

Tucidinostat

Jinmei Zhou

Tao Wang

Tao wang

To evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.

Cyclin-dependent kinase (CDK) 4/6 inhibitors have changed the treatment pattern of patients with hormone receptor-positive HER2-negative advanced breast cancer significantly prolongling patients'PFS and OS,but there is no optimal therapy after its progression.Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor, ACE trial demonstrated that tucidinostat plus exemestane improved PFS compared with placebo plus exemestane in HR+,MBC patients that progressed after previous endocrine therapy,only 7 patients enrolled in the trial had previously received CDK4/6 inhibitors.The aim of this trial is to evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.

Outcome of Tucidinostat-Based Therapy in HR+ Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor

A Single-center Study of the Outcome of Tucidinostat-Based Therapy in Hormone Receptor-Positive Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor Therapy

Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

Beijing 302 Hospital

Pharmaceutical Solutions

Antineoplastic Agents

Gastrointestinal Agents

Herbal and Botanical

Fulvestrant

Castor Oil

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Castor

Patients receive 30 mg Chidamide twice per week. Fulvestrant 500mg (2 syringes of Fulvestrant 250mg), Fulvestrant 500 mg i.m. every 28 (+/- 3) days plus an additional 500 mg on day 14 (+/-3) of first month only.

Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

30 mg, administered orally twice per week (BIW)

Fulvestrant was supplied as a castor oil based solution in clear neutral glass pre-filled syringes. Each syringe will contain 250 mg of fulvestrant in 5 ml.

Anqin Zhang

The purpose of the study is evaluate the efficacy and safety of tucidinostat in combination with fulvestrant in patients with hormone-receptor positive advanced breast cancer.

Hormone-receptor positive breast cancer is the most common subtype in breast cancer. Tucidinostat is an oral subtype-selective histone deacetylase inhibitor, which showed preliminary signs of encouraging anti-tumour activity in patients with advanced hormone-receptor positive breast cancer in the previous studies. The aim of this study is to evaluate the efficacy and safety of Tucidinostat in combination with fulvestrant in patients with recurrent or metastatic hormone-receptor positive breast cancer.

Tucidinostat and Fulvestrant in Hormone-receptor Positive Advanced Breast Cancer

Trial of Tucidinostat in Combination With Fulvestrant in Patients With Hormone-receptor Positive Advanced Breast Cancer

PFS was defined as the time from treatment until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), or death by any cause, whichever is first met.

Defined as from the date of treatment to date of death, irrespective of cause.

Defined as numbers of patients achieved complete response and partial response of treatment.

Defined as from the first date when criteria for response is met until the first date when the criteria for progression or death is met.

ORR is defined as percentage of participants with Complete Response, Partial Response or Stable Disease≥24 weeks, assessed by the investigators according to the RECIST v1.1.

Guangdong Women and Children Hospital

Chief Physician

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Tislelizumab

Antineoplastic Agents, Immunological

Subjects receive Tucidinostat 30mg orally biw and Tislelizumab 200 mg intravenously (IV) Q3W.

Subjects receive Tislelizumab 200 mg intravenously (IV) Q3W.

Yu Chen

Caicun Zhou

A Randomized, Double-blind, Controlled, Multi-center Phase 2 Clinical study to Investigate the Efficacy and Safety of Tucidinostat (Chidamide) Combined with Tislelizumab as First-line Treatment for PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC

A Randomized, Double-blind, Controlled, Multi-center Phase II Clinical Trial of Tucidinostat Combined With Tislelizumab as First-line Treatment for PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

PFS assessed by investigator per RECIST v1.1, measured from the date of randomization until progression or death, whichever is first met.

Proportion of participants who have a partial response (PR) or complete response (CR) to therapy according to RECIST 1.1 or iRECIST.

PFS assessed by investigator per iRECIST, measured from the date of randomization until progression or death, whichever is first met.

From the first dose of treatment until the date of death from any cause.

Proportion of participants in partial, complete or stable disease according to RECIST 1.1 or iRECIST.

From the first date of response until the date of first documented progression according to RECIST 1.1 or iRECIST.

Proportion of subjects who did not have disease progression(according to RECIST1.1 or iRECIST) or death at 6 months after randomization.

TTP is measured from date of randomization until progression(according to RECIST1.1 or iRECIST) not including death.

TTR is measured from date of randomization until response

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Chipscreen Biosciences, Ltd.

Reproductive Control Agents

Exemestane

Leuprolide

Goserelin

Aromatase Inhibitors

Enzyme Inhibitors

Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.

Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26

Exemestane: 25 mg QD from week 1 to week 26.

If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.

Ovarian function suppression

Ying Lin, MD

This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore the genetic model which can predict neoadjuvant endocrine therapeutic results.

This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks. Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the therapeutic results. Genetic testing will also be performed before and after neoadjuvant treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS evaluated ORR, pCR, AE and RCB are secondary end point.

Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）

ORR is defined as percentage of participants with Complete Response and Partial Response, assessed by the investigators using MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Contrast-enhanced ultrasound will also be performed to assess ORR

The percentage of participants with pathologically assessed ypT0 and ypTis of breast disease.

All advese effect events related with Tucidinostat and Exemestane.

Pathologilly assessed residual cancer burden according to MD Anderson protocol.

First Affiliated Hospital, Sun Yat-Sen University

Vice Director of Department of Breast Surgery

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Amino Acids

Apatinib

Azacitidine

Dasatinib

Antimetabolites

Protein Kinase Inhibitors

Tyrosine Kinase Inhibitors

Tyrosine

T1 subtypes based on next generation sequencing results

T2 subtypes based on next generation sequencing results

T3.1 subtypes based on next generation sequencing results

T3.2 subtypes based on next generation sequencing results

Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes

Azacitidine Injection

Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes

Linperlisib

Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes

SHR2554

Camrelizumab and Apatinib will be administered in T3.2 subtypes

Camrelizumab

Weili Zhao

Pengpeng Xu

Weili Zhao, M.D. and Ph.D

This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.

A Umbrella Study in R/R PTCL Guided by Molecular Subtypes

A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes

Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Overall survival was defined as the time from the date of enrollment to the date of death from any cause.

Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Ruijin Hospital

First Deputy Director, Hematology Department

Antirheumatic Agents

Anti-Inflammatory Agents

Cyclophosphamide

Prednisone

Epirubicin

Tucidinostat, Azacitidine combined with CHOP

Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast.

CHOP chemotherapy:

* Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1;
* Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1;
* Vinoresin (VDS) 4mg intravenous infusion, day 1;
* Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment

Yan Zhang

Daobin Zhou

Daobin Zhou, Doctor

This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma

Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL

Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

the total proportion of patients with complete response (CR) and partial response (PR)

Time from treatment until disease progression or death

Time from treatment until death from any cause

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0

Peking Union Medical College Hospital

Deputy Chief Physician

Capecitabine

Letrozole

Anastrozole

Histone Deacetylase Inhibitors

This arm is divided into two groups. The main difference of this two groups lies in the selection of endocrine therapy. One is supposed to choose aromatase inhibitor, and the other is fulvestrant. The principle of making choice is based on the history of endocrine drug use.

20mg each time, orally 30 minutes after dinner, 3 weeks for a cycle, administered on day 1, day 4, day 8, day 11, day 15,and day 18 of each cycle (twice a week, at least 3 days between each administration)

500mg orally three times a day (continuously)

Anastrozole, 1mg, orally once daily or Letrozole, 2.5mg, orally once daily or Exemestane , 25mg, orally once daily or fulvestrant 500 mg each time, intramuscularly, injected on the 1st day and 15th day of the 1st cycle, and on the 1st day for subsequent cycle( 4 weeks for one cycle)

Endocrine Therapy

Susen Wang, MD

shusen wang, MD

The study is designed to explore the clinical benefit following treatment with tucidinosta in combination with metronomic capecitabine and endocrine therapy in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have received CDK4/6 Inhibitor treatment.

Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor.

Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor：a Prospective, Single-arm, Phase II Clinical Trial.

Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1 recorded from randomization until disease progression or death due to any cause

Time from randomization to the first documentation of objective tumor progression or to death due to any cause.

Disease control is defined as complete response (CR), partial response (PR), or stable disease (SD) ≥24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.

Time from randomization to date of death due to any cause. according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.

wang shusen

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Chidamide Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.)

Tucidinostat Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.)

ou BAI, doctor

Ou BAI, doctor

A phase II，single arm，open-label study to assess Maintenance Therapy of Chidamide in Patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma with complete response after completion of prior chemotherapy

Objective to evaluate the efficacy and safety of maintenance therapy with Chidamide in patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma（DLBCL） with complete response after completion of prior chemotherapy, so as to provide the basis for the application of Chidamide in HBV positive DLBCL

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Outcome of Tucidinostat-Based Therapy in HR+ Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor	NCT05276713	Breast Cancer	Tucidinostat	18 Years -	Beijing 302 Hospital
Tucidinostat and Fulvestrant in Hormone-receptor Positive Advanced Breast Cancer	NCT04999540	Breast Cancer	Tucidinostat Fulvestrant	18 Years - 75 Years	Guangdong Women and Children Hospital
A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC	NCT05519865	Non Small Cell ...	Tucidinostat Tislelizumab	18 Years -	Chipscreen Biosciences, Ltd.
Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer	NCT04465097	Breast Cancer	Tucidinostat Exemestane Ovarian functio...	18 Years -	First Affiliated Hospital, Sun Yat-Sen University
Tucidinostat and Fulvestrant in Hormone-receptor Positive Advanced Breast Cancer	NCT04999540	Breast Cancer	Tucidinostat Fulvestrant	18 Years - 75 Years	Guangdong Women and Children Hospital
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes	NCT05559008	Peripheral T Ce...	Azacitidine Inj... Dasatinib Linperlisib Tucidinostat SHR2554 Camrelizumab Apatinib	18 Years -	Ruijin Hospital
Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma	NCT05075460	T-cell Lymphoma	Tucidinostat, A...	18 Years - 70 Years	Peking Union Medical College Hospital
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes	NCT05559008	Peripheral T Ce...	Azacitidine Inj... Dasatinib Linperlisib Tucidinostat SHR2554 Camrelizumab Apatinib	18 Years -	Ruijin Hospital
Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor.	NCT05411380	Breast Cancer	Tucidinostat Capecitabine Endocrine Thera...	18 Years - 75 Years	Sun Yat-sen University
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma	NCT04661943	Diffuse Large B...	Tucidinostat	18 Years - 75 Years	The First Hospital of Jilin University
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma	NCT04661943	Diffuse Large B...	Tucidinostat	18 Years - 75 Years	The First Hospital of Jilin University
Phase III Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed Double-Expressor DLBCL	NCT04231448	Diffuse Large B...	R-CHOP(Rituxima... Tucidinostat Placebo	18 Years - 80 Years	Chipscreen Biosciences, Ltd.

Spots Global Cancer Trial Database for tucidinostat

Every month we try and update this database with for tucidinostat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.