地西他滨/西达尿苷(Decitabine/Cedazuridine) - 药物靶点：CDA x DNMT1_在研适应症：急性髓性白血病，慢性粒单核细胞白血病，骨髓增生异常综合征_专利_临床

概要

基本信息

药物类型

小分子化药

别名

(4R)-2'-Deoxy-2',2'-difluoro-3,4,5,6-tetrahydrouridine、Decitabine/cedazuridine、Decitabine/E7727

+ [6]

靶点

CDA x DNMT1

作用机制

CDA抑制剂(胞嘧啶核苷脱氨酶抑制剂)、DNMT1抑制剂(DNA（胞嘧啶-5）-甲基转移酶-1抑制剂)

治疗领域

癌症血液及淋巴系统疾病其他疾病+ [4]

在研适应症

急性髓性白血病慢性粒单核细胞白血病骨髓增生异常综合征+ [13]

非在研适应症

造血干细胞移植IDH1突变急性髓性白血病复发性骨髓增生异常综合征+ [1]

原研机构

Astex Pharmaceuticals, Inc.

在研机构

The University of Texas MD Anderson Cancer Center

Astex Pharmaceuticals, Inc.

Taiho Oncology, Inc.

+ [9]

非在研机构

FORMA Therapeutics, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2020-07-07),

骨髓增生异常综合征

最高研发阶段(中国)临床1/2期

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚)

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结构

分子式C9H14F2N2O5

InChIKeyVUDZSIYXZUYWSC-DBRKOABJSA-N

CAS号1141397-80-9

查看全部结构式(2)

关联

46

项与地西他滨/西达尿苷相关的临床试验

NCT06577441 / Not yet recruiting临床2期IIT

A Randomized Phase II Trial of Enasidenib-Based Therapies Versus Cedazuridine-Decitabine in Higher-Risk IDH2-Mutated Myelodysplastic Syndrome: A MyeloMATCH Treatment Trial

This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Enasidenib is an enzyme inhibitor that may stop the growth of cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with enasidenib may be effective in treating patients with higher-risk IDH2-mutated MDS.

开始日期2024-10-18

申办/合作机构

National Cancer Institute

NCT06284460 / Not yet recruiting临床1/2期IIT

Phase I/II Study of a Combination of Decitabine and Cedazuridine (ASTX727) and ASTX029, an ERK Inhibitor, for Patients With RAS Pathway Mutant Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of ASTX029 that can be given in combination with ASTX727 to participants who have RAS-mutant MDS or MDS/MPN. The goal of Part 2 of this clinical research study is to learn if the dose of ASTX029 found in Part 1 can help to control the disease when used in combination with ASTX727.

开始日期2024-07-31

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06297629 / Withdrawn临床2期IIT

A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation

To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant.

开始日期2024-07-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

100 项与地西他滨/西达尿苷相关的临床结果

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100 项与地西他滨/西达尿苷相关的转化医学

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100 项与地西他滨/西达尿苷相关的专利（医药）

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29

项与地西他滨/西达尿苷相关的文献（医药）

2024-09-01·Clinical Lymphoma Myeloma & Leukemia

Oral Decitabine/Cedazuridine Is an Effective Ambulatory Therapy for Patients With Myelofibrosis Refractory to JAK2 Inhibitor Therapy

Article

作者: Dueck, Amylou ; Ginzburg, Yelena ; Handa, Shivani ; Sivakumar, Ganesh ; Mascarenhas, John O ; Tremblay, Douglas ; Kremyanskaya, Marina ; Hoffman, Ronald ; Srisuwananukorn, Andrew

BACKGROUND:

Outcomes are dismal for patients with myelofibrosis (MF) who are no longer responsive to JAK2 inhibitors (JAKi) and/or have increasing blast cell numbers. Although prior reports have suggested the benefits of intravenous decitabine (DAC) combined with ruxolitinib for patients with Myeloproliferative Neoplasm (MPN) accelerated/blast phase (AP/BP), decitabine-cedazuridine (DEC-C), an oral fixed-dose combination providing equivalent pharmacokinetic exposure, has not been evaluated in MF.

METHODS:

We conducted a retrospective analysis of 14 patients with high-risk MF refractory to ruxolitinib or MPN-AP (10-19% blasts) treated with DEC-C +/- JAKi at Mount Sinai Hospital from 2021 to 2024.

RESULTS:

The cohort was elderly (median age,76 years) and almost uniformly possessed high risk mutations with 13 of the 14 patients progressing on JAKi therapy. With a median follow-up of 9.4 months, the median overall survival (OS) was 29 months for the entire cohort. Median OS was 10.8 months for MPN-AP and was not reached for ruxolitinib refractory MF patients. All patients (n = 9) receiving > 4 cycles of DEC-C had clinical benefit exemplified by a reduction in blast cell numbers, spleen size, and lack of progression to MPN-BP (78%). Furthermore, 3/14 patients proceeded to allogeneic stem cell transplant. Myelosuppression was a common adverse event which was managed by reducing the number of days of administration of DEC-C from 5 to 3 per cycle.

CONCLUSIONS:

This report demonstrates the feasibility, tolerability, and clinical benefit of an exclusively ambulatory regimen for high-risk, elderly patients with advanced MF which warrants further evaluation in a prospective clinical trial.

2024-04-01·The Lancet. Haematology

Oral decitabine and cedazuridine plus venetoclax for older or unfit patients with acute myeloid leukaemia: a phase 2 study

Article

作者: Garcia-Manero, Guillermo ; Kadia, Tapan ; Short, Nicholas ; Pierce, Sherry ; Alvarado, Yesid ; Bataller, Alex ; Jain, Nitin ; Masarova, Lucia ; Islam, Rabiul ; Konopleva, Marina ; Kornblau, Steven ; Ravandi, Farhad ; Bazinet, Alexandre ; Montalban-Bravo, Guillermo ; Maiti, Abhishek ; Issa, Ghayas ; Abuasab, Tareq ; Daver, Naval ; DiNardo, Courtney D ; Kantarjian, Hagop ; Yilmaz, Musa ; Huang, Xuelin ; Jabbour, Elias ; Montalbano, Kathryn ; Rausch, Caitlin R

BACKGROUND:

Hypomethylating agents combined with venetoclax are effective regimens in patients with acute myeloid leukaemia who are ineligible for intensive chemotherapy. Decitabine and cedazuridine (ASTX727) is an oral formulation of decitabine that achieves equivalent area-under-curve exposure to intravenous decitabine. We performed a single centre phase 2 study to evaluate the efficacy and safety of ASTX727 plus venetoclax.

METHODS:

This study enrolled patients with newly diagnosed (frontline treatment group) acute myeloid leukaemia who were ineligible for intensive chemotherapy (aged ≥75 years, an Eastern Cooperative Oncology Group [ECOG] performance status of 2-3, or major comorbidities) or relapsed or refractory acute myeloid leukaemia. Being aged 18 years or older and having an ECOG performance status of 2 or less were requirements for the relapsed or refractory disease treatment cohort, without any limits in the number of previous lines of therapy. Treatment consisted of ASTX727 (cedazuridine 100 mg and decitabine 35 mg) orally for 5 days and venetoclax 400 mg orally for 21-28 days in 28-day cycles. The primary outcome was overall response rate of ASTX727 plus venetoclax. Living patients who have not completed cycle one were not evaluable for response. Safety was analysed in all patients who started treatment. This study was registered on ClinicalTrials.gov (NCT04746235) and is ongoing. The data cutoff date for this analysis was Sept 22, 2023.

FINDINGS:

Between March 16, 2021, and Sept 18, 2023, 62 patients were enrolled (49 frontline and 13 relapsed or refractory) with a median age of 78 years (IQR 73-82). 36 (58%) were male; 53 (85%) were White, 4 (6%) Black, 2 (3%) Asian and 3 (5%) other or did not answer. 48 (77%) of 62 patients were European LeukemiaNet 2022 adverse risk, 24 (39%) had antecedent myelodysplastic syndromes, 12 (19%) had previously failed a hypomethylating agent, ten (16%) had therapy-related acute myeloid leukaemia, and 11 (18%) had TP53 mutations. The median follow-up time was 18·3 months (IQR 8·8-23·3). The overall response rate was 30 (64%) of 47 patients (95% CI 49-77) in frontline cohort and six (46%) of 13 patients (19-75) in relapsed or refractory cohort. The most common grade 3 or worse treatment-emergent adverse events were febrile neutropenia in 11 (18%) of 62 patients, pneumonia in eight (13%), respiratory failure in five (8%), bacteraemia in four (6%), and sepsis in four (6%). Three deaths occurred in patients in remission (one sepsis, one gastrointestinal haemorrhage, and one respiratory failure) and were potentially treatment related.

INTERPRETATION:

ASTX727 plus venetoclax is an active fully oral regimen and safe in most older or unfit patients with acute myeloid leukaemia. Our findings should be confirmed in larger multicentric studies.

FUNDING:

MD Anderson Cancer Center Support Grant, Myelodysplastic Syndrome/Acute Myeloid Leukaemia Moon Shot, Leukemia SPORE, Taiho Oncology, and Astex Pharmaceuticals.

2024-01-01·Therapeutic Advances in Hematology

Patients’ perspectives on oral decitabine/cedazuridine for the treatment of myelodysplastic syndromes/neoplasms

Article

作者: Washington, Terri ; Perepezko, Kate ; Salimi, Tehseen ; Epstein, Robert S ; Zeidan, Amer M

Background::

Hypomethylating agents (HMAs) are guideline-recommended treatment for higher-risk myelodysplastic syndromes/neoplasms (MDS). However, a prior survey of patients with MDS reported challenges with intravenous (IV) and subcutaneous (SC) HMA therapies, including pain related to treatment administration and interference with daily activities; most patients also indicated a preference to switch to an oral therapy if one were available.

Objectives::

This study evaluated the perspectives of US patients with MDS receiving oral decitabine/cedazuridine (DEC-C), an alternative to IV/SC HMAs.

Methods::

An online survey was conducted among adult patients with MDS in the United States (10 November 2022 to 5 December 2022) who had filled a prescription for oral DEC-C between 2021 and 2022.

Results::

A total of 150 patients completed the survey; 61% were aged ⩾60 years and 63% were male. Of these, 123 (82%) were still receiving oral DEC-C, and 27 (18%) had stopped oral DEC-C treatment. Half (50%) of patients had received oral DEC-C for ⩾6 months. The majority reported that treatment was convenient (83%) and that they were satisfied with treatment (86%). Most patients also reported very little/no interference with regular daily activities (82%), social activities (78%), and productivity (78%). When queried about negative impacts on quality of life (QOL), treatment side effects were the most commonly reported (30% of respondents). Among patients who had previously received IV/SC HMAs ( n = 91), most agreed that oral DEC-C interfered less with daily life (91%) and had experienced improvement in QOL (85%) compared with previous treatment; 91% reported that oral DEC-C reduced the number of times they needed to travel to a healthcare facility.

Conclusion::

Survey results suggest very little/no impact on regular daily activities and improved QOL with oral DEC-C relative to IV/SC HMAs, highlighting the potential for oral DEC-C to reduce the treatment burden associated with parenteral HMA therapy.

23

项与地西他滨/西达尿苷相关的新闻（医药）

2024-09-12

·GlobeNewswire-Health Care

Biosplice Therapeutics Announces Initiation of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Trial Sponsored by the National Cancer Institute (NCI)

Biosplice expands its clinical candidate, cirtuvivint, as standalone treatment and combination therapy in patients with AML and MDS, representing next step in ongoing collaboration with the NCISAN DIEGO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering advancements in small molecule inhibition of CDC-like kinases (CLK) and Dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the NCI-sponsored Investigational New Drug (IND) application for cirtuvivint. This small molecule inhibitor of CLK and DYRK kinases is in development for the treatment of hematological malignancies and solid tumors. This clearance allows for the initiation of a new clinical trial of cirtuvivint, both as a standalone treatment for patients with relapsed/refractory AML and MDS as well as in combination with ASTX727 for patients with frontline high-risk MDS. The clinical study (NCI protocol 10674, NCT06484062) will be sponsored by the NCI, part of the National Institutes of Health, with Dr. Maximilian Stahl from the Dana-Farber Cancer Institute serving as principal investigator. This trial will be conducted in participating centers of the NCI’s Experimental Therapeutics Clinical Trials Network including Dana-Farber Cancer Institute and Memorial Sloan Kettering Cancer Center. The study aims to enroll up to 52 patients and will be conducted under the Cooperative Research and Development Agreement (CRADA) executed between Biosplice and the NCI. “We are thrilled that the NCI has received FDA clearance to launch this groundbreaking new Phase 1 trial of cirtuvivint in liquid tumors, both as monotherapy and in combination with ASTX727,” stated Dr. Yusuf Yazici, Chief Medical Officer of Biosplice. “This milestone is a major step forward in our efforts to advance innovative treatments targeting CLKs and DYRKs. Given that dysregulated alternative splicing is commonly implicated in AML and MDS, cirtuvivint’s ability to regulate alternative splicing via CLK and DYRK inhibition may provide a promising new therapeutic pathway for patients. Based on compelling anti-tumor activity across both solid and liquid tumors in in vitro and in vivo models, as well as data from two prior Phase 1 trials in solid tumors, cirtuvivint promises to greatly improve outcomes for patients in these critical and underserved areas.” This milestone highlights the ongoing collaboration between Biosplice and the NCI’s Cancer Therapy Evaluation Program (CTEP) through the NCI Experimental Therapeutics (NCI-NExT) program. After extensive evaluation, cirtuvivint was chosen for inclusion by NCI in the NExT programs following a competitive review. NCI-NExT partners with external researchers and leading scientific experts to accelerate the development of the most promising and innovative therapies, guiding them from early-stage research through to regulatory approval. About Biosplice:Biosplice stands at the forefront of research concentrating on the study and regulation of Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs). These kinases play pivotal roles in cell cycle regulation, splicing, and neurodevelopment, marking them as critical targets for therapeutic intervention in a range of diseases, including osteoarthritis, cancer, neurological disorders, and diabetes. With a robust chemical platform for kinase inhibition and a deep understanding of kinase signaling pathways, Biosplice leverages cutting-edge technologies to discover and develop highly selective kinase inhibitors. Biosplice’s drugs in clinical development include lorecivivint for osteoarthritis (completed Phase 3) and cirtuvivint for numerous cancers, with a broad preclinical pipeline that encompasses Alzheimer’s disease, diabetes and other degenerative conditions. About Cirtuvivint:Cirtuvivint is a small molecule inhibitor of CLK and DYRK kinases, which are increasingly recognized as key drivers of various cancers. By targeting these kinases, cirtuvivint modulates alternative pre-mRNA splicing, which may reduce the expression of genes vital for tumor growth, survival, and drug resistance. The compound has shown broad anti-tumor activity across a range of solid and liquid tumors in extensive preclinical studies. Cirtuvivint has also been investigated for the treatment of advanced solid tumors in two clinical trials. The first, SM08502-ONC-01 (NCT03355066), was a first-in-human dose escalation study designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors. The second, SM08502-ONC-03 (NCT05084859), was a Phase 1b trial assessing the efficacy of cirtuvivint in combination with standard treatments for patients with advanced castration-resistant prostate cancer, advanced non-small cell lung cancer, and advanced colorectal cancer. Learn more at https://www.biosplice.com

临床1期临床申请临床3期

2024-06-20

·PRNewswire

Escend Announces Poster Presentation at the Annual Meeting of the European Hematology Association (EHS) from an Investigator-Initiated Phase I/II study evaluating ES-3000 in Myelodysplastic Syndrome (MDS)

MENLO PARK, Calif., June 20, 2024 /PRNewswire/ -- Escend Pharmaceuticals, Inc., a privately held oncology company, announced today a poster presentation with initial data from the Australasian Leukaemia and Lymphoma Group's (ALLG) investigator-initiated Phase I/II platform study (MYDAS-T MDS05 domain 1) evaluating ES-3000 alone and in combination with ASTX727 at European Hematology Association (EHS) in Madrid, Spain. The poster is entitled, 'Combining oral Wnt/β catenin/inflammasome pathway inhibitor, a bis-benzylisoquinoline alkaloid (ES-3000) with oral decitabine/cedazuridine (ASTX727)* as a treatment strategy for myelodysplasia'. The primary objectives of the initial phase of the trial are to assess the safety profile of ES-3000 and determine the recommended phase 2 dose and dosing schedule of ES-3000 in combination with fixed-dose decitabine/cedazuridine (ASTX727). The results indicate a response in 40% of evaluable patients who received ES-3000 as a single agent. The dose-limiting toxicities as per BION modeling allowed the study to dose escalate. A copy of the poster is available at Escend Pharmaceuticals' website About ES-3000 ES-3000 is a small molecule, oral investigational product that reduces leukemic stem cells by β-catenin and Calmodulin protein-dependent kinase II gamma (CamKIIγ). ES-3000 is being developed for the treatment of myeloid malignancies including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and myelodysplastic syndrome (MDS). About Escend Escend's development strategy is to select drug candidates with established clinical safety that have not yet achieved US marketing approval and develop them for oncology based on new mechanism of action details, where their effects on specific cellular pathways can be leveraged for the development of novel therapeutics. About Australasian Leukaemia and Lymphoma Group's (ALLG) The Australasian Leukaemia and Lymphoma Group (ALLG) is Australia's and New Zealand's only collaborative clinical trial organisation that sponsors local investigator-initiated clinical trials. Established in 1973, the ALLG's membership of over 1,300 blood cancer health professionals at 94 networked sites includes haematologists, clinician researchers, scientists and nurses treating leukaemia, lymphoma, myeloma, myelodysplastic syndromes and other haematological malignancies. The ALLG plans, designs, conducts, monitors and publishes investigator initiated clinical trials to create better treatments and better lives for patients with blood cancers. For further information about this press release, please contact Saira Bates ([email protected]) or visit *Astex Pharmaceuticals study drug SOURCE Escend Pharmaceuticals, Inc.

临床研究临床结果

2024-04-01

·FierceBiotech

'One-two punch' of epigenetic cancer drugs could knock out colorectal cancer cells

An upcoming trial in patients with colorectal cancer will be the first to test an DNMT inhibitor and an EZH2 inhibitor together in any type of cancer. A pair of epigenetic cancer drugs packs a “one-two punch” against colorectal tumors to knock them out more effectively than either medication alone, a new study in cells suggests. In a journal article published March 27 in Science Advances, a team of researchers led by scientists from the Van Andel Institute in Grand Rapids, Michigan showed that a low dose of the DNA methyltransferase (DNMT) inhibitor decitabine combined with Tithe EZH2 inhibitor tazemetostat successfully induced changes that would make cancer cells more vulnerable to destruction by the immune system. The chemotherapy decitabine is commercialized by Eisai as Inqovi; tazemetostat is commercialized by Ipsen as Tazverik. Neither company was involved in the study. While agents in both classes of drugs are FDA approved to treat blood cancer, they haven't had much success in solid tumors such as colorectal cancer, Scott Rothbart, Ph.D., the study’s corresponding author, said in a press release. “Our findings highlight the promise of combination cancer therapies by revealing how these two medications interact, with the DNMT inhibitor priming cancer cells in a way that makes the EZH2 inhibitor more effective.” “Epigenetic” is a term that refers to typically reversible modifications made to genes that do not directly alter the genes themselves, but rather affect their expression. Cancer progression involves many epigenetic changes both to the cancer cells themselves and to the immune cells that would otherwise destroy them. Scientists have attempted to destroy cancer by countering these changes pharmacologically and restoring the expression of anti-cancer genes. The most established means of doing so is with histone deacetylase inhibitors, or HDAC inhibitors, such as Merck’s Zolinza (vorinostat) for lymphoma and Acrotech Biopharma’s Beleodaq (belinostat) for myeloma. The only other FDA-approved DNMT inhibitor besides Inquovi is Celgene’s acute myeloid leukemia drug Vidaza (azacitidine). Tazverik is the sole EZH2 inhibitor with FDA approval. Earlier work by Van Andel Institute researchers showed that DNMT inhibitors cause cancer cells to act as though they’ve been infected by a virus, making them more vulnerable to one’s immune system. For the new study, the researchers hypothesized that because DNMT inhibitors alter the cells in a way that could make EZH2 inhibitors more effective, they would work better together than separately. To see whether this was the case, the researchers started by testing them against different types of colorectal cancer cells on their own, then looked at them in combination. The results backed up their rationale: EZH2 inhibitors compounded the changes initiated by the DNMT inhibitors, boosting the duo’s effectiveness. The findings are the basis for an upcoming clinical trial that will evaluate the pair against colorectal cancer in patients. Combinations of DNMT inhibitors and HDAC inhibitors have been tested in clinical trials to mixed results, the study noted. The new trial will be the first to evaluate a DNMT inhibitor and an EZH2 inhibitor. Future studies should evaluate the pair with immunotherapies, too, Rothbart noted in the release. There’s evidence in preclinical models that the viruslike changes the drugs make in the cells could lead to a better response to drugs that boost the immune system. “These data suggest future directions for testing whether DAC and TAZ treatments might improve tumor response to immunomodulating agents,” the researchers wrote in the study.

上市批准免疫疗法临床研究

100 项与地西他滨/西达尿苷相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	地西他滨/西达尿苷	L01XY	DB15694

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性髓性白血病	欧盟	Otsuka Pharmaceutical Netherlands B.V.	2023-09-15
急性髓性白血病	冰岛	Otsuka Pharmaceutical Netherlands B.V.	2023-09-15
急性髓性白血病	列支敦士登	Otsuka Pharmaceutical Netherlands B.V.	2023-09-15
急性髓性白血病	挪威	Otsuka Pharmaceutical Netherlands B.V.	2023-09-15
慢性粒单核细胞白血病	澳大利亚	Otsuka Australia Pharmaceutical Pty Ltd.	2020-10-29
骨髓增生异常综合征	美国	Otsuka Pharmaceutical Co., Ltd.	2020-07-07

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨髓增生异常/骨髓增生性疾病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-07-31
骨髓增生性疾病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-07-31
血液肿瘤	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-07-01
血液肿瘤	临床2期	美国	Astex Pharmaceuticals, Inc.	2024-07-01
造血干细胞移植	临床2期	美国	Astex Pharmaceuticals, Inc.	2024-07-01
造血干细胞移植	临床2期	美国	The University of Texas MD Anderson Cancer Center	2024-07-01
神经纤维肉瘤	临床2期	美国	Astex Pharmaceuticals, Inc.	2021-04-29
IDH1突变急性髓性白血病	临床2期	-	FORMA Therapeutics, Inc.	2019-08-27
IDH1突变急性髓性白血病	临床2期	-	Astex Pharmaceuticals, Inc.	2019-08-27
复发性骨髓增生异常综合征	临床2期	-	FORMA Therapeutics, Inc.	2019-08-27

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ES-3000 (EHA2024)	临床1/2期	骨髓增生异常综合征	8	ES-3000 60mg TID	積憲鹹範壓鑰繭鏇蓋獵(構範鹽艱選鏇顧觸簾構) = One patient progressed and subsequently died of infective complications (colitis) attributable to progressive disease in cycle 2 顧蓋壓鹽齋齋繭憲網顧 (鹽衊窪鹹衊構鑰夢獵廠 ) 更多	-	2024-05-14
ASTX727-01-B, ASCERTAIN (EHA2024)	临床2/3期	骨髓增生异常综合征 TP53 multi-hit mutations	180	Oral DEC-C (ASTX727)	窪顧淵鏇製憲鬱獵獵獵(壓鹽願簾膚夢憲餘獵憲) = 製簾憲構網鏇淵壓網壓窪醖願窪願醖獵願艱餘 (鏇蓋淵遞膚顧鏇衊糧鹽 ) 更多	积极	2024-05-14
				IV decitabine	鬱餘膚範襯遞鹽夢壓鬱(築網鹽選糧衊艱壓積網) = 選簾繭觸觸鹹範顧壓醖簾願餘獵鏇壓繭廠選衊 (製鑰齋夢壓觸願鬱壓鹽 ) 更多
EHA2024	N/A	慢性粒单核细胞白血病	50	Azacitidine	獵鹹憲壓艱鏇壓願鹽鹽(夢繭廠壓艱膚鏇醖顧憲) = 願製鹽餘夢醖窪壓鑰鹽淵鹽蓋製製鏇鏇醖淵構 (壓鏇齋鑰醖願夢網顧窪 ) 更多	-	2024-05-14
				Decitabine-cedazuridine	獵鹹憲壓艱鏇壓願鹽鹽(夢繭廠壓艱膚鏇醖顧憲) = 觸獵鏇壓積顧築鹽鬱蓋淵鹽蓋製製鏇鏇醖淵構 (壓鏇齋鑰醖願夢網顧窪 ) 更多
NCT04746235 (Pubmed) 人工标引	临床2期	急性髓性白血病	62	ASTX727 + venetoclax 400 mg	糧淵願鏇齋構獵衊選襯(鬱鑰餘構獵衊膚遞衊獵) = 憲鬱鏇壓繭糧繭獵築鏇鏇壓膚選憲膚鹹築遞願 (鬱築鹽艱淵襯遞鏇願鏇 ) 更多	积极	2024-04-01
				ASTX727 + venetoclax 400 mg (newly diagnosed acute myeloid leukaemia)	糧淵願鏇齋構獵衊選襯(鬱鑰餘構獵衊膚遞衊獵) = 選網鏇蓋衊製齋簾網願鏇壓膚選憲膚鹹築遞願 (鬱築鹽艱淵襯遞鏇願鏇, 49 ~ 77)
NCT03306264 (ASCERTAIN, Pubmed) 人工标引	临床3期	慢性粒单核细胞白血病 \| 骨髓增生异常综合征	133	ASTX727	觸廠選憲願獵衊衊窪襯(糧鹹願願鏇夢選襯齋壓) = 糧築顧積憲衊憲範願遞廠鹹齋糧齋鑰網壓夢廠 (鬱衊網網膚窪範襯憲鑰, 92·66 ~ 105·60) 更多	积极	2024-01-01
				decitabine	壓願鏇選膚廠壓繭獵鹹(網簾築繭選淵淵構夢醖) = 鬱廠衊鏇齋憲廠鬱製網膚鬱鹽積觸衊網衊選獵 (壓簾製獵淵鹽鏇齋襯淵 )
ASCERTAIN (ASH2023)	N/A	骨髓增生异常综合征	-	IV decitabine	齋窪願範網艱遞觸醖夢(襯網網願網觸衊鬱鹽鹹) = 糧艱鬱齋願範壓窪憲製鹹鏇網鹹衊選鏇繭鹽製 (製願艱鏇鏇製鹹窪顧鬱 )	-	2023-12-11
ASH2023	临床1/2期	-	51	ASTX727 + VEN + IVO	範觸鹹鏇網齋網選鏇製(築廠遞鹽繭鏇醖積蓋餘) = 鹹膚構獵夢鏇簾製鏇簾製遞鹽壓壓製鬱鬱壓鹹 (構鑰淵齋網醖憲築遞願 ) 更多	-	2023-12-11
				ASTX727 + VEN + ENA	範觸鹹鏇網齋網選鏇製(築廠遞鹽繭鏇醖積蓋餘) = 醖膚窪廠廠醖遞餘憲蓋製遞鹽壓壓製鬱鬱壓鹹 (構鑰淵齋網醖憲築遞願 ) 更多
NCT04746235 (ASH2023)	临床2期	急性髓性白血病	52	ASTX727 (Decitabine/Cedazuridine) plus Venetoclax	蓋構憲觸窪窪憲製齋選(簾餘製鹹憲鏇繭艱壓顧) = 淵構顧夢憲簾簾鹹簾廠遞壓鹹鑰願鹹願鹽窪齋 (選糧廠醖餘範鏇廠憲製 ) 更多	-	2023-12-11
ASH2023	临床1/2期	复发性急性髓细胞白血病	15	ASTX727, Gilteritinib, and Venetoclax	簾齋衊範糧齋襯齋鹹範(積積鹽觸廠糧觸構淵齋) = 築築憲鹽夢夢遞餘壓衊廠鹹壓糧製夢鬱鑰膚夢 (艱衊鏇獵鹹衊齋構構製 )	-	2023-12-10
NCT05360160 (SAVE, ASH2023) 人工标引	临床1/2期	急性髓性白血病 KMT2Ar \| NPM1mt \| NUP98r	8	Revumenib+ASTX727+Venetoclax	齋糧壓願廠願鹽願糧鬱(糧夢願構鑰夢醖築鏇鹽) = The most common all-grade treatment-related adverse events (TRAEs) in ≥25% of pts were febrile neutropenia (63%), hyperphosphatemia (63%), nausea (63%), and AST/ALT elevation (25%). 構餘膚蓋齋醖衊衊鬱鹽 (獵積簾製窪獵糧壓鹹糧 ) 更多	积极	2023-12-09