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Last update 23 Mar 2025

Guadecitabine Sodium

Last update 23 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Decitabine deoxyguanosine, Decitabine deoxyguanosine dinucleotide, DNMT-inhibitor-SGI-110

+ [6]

Target

DNMT1 x DNMTs

Action

inhibitors

Mechanism

DNA methyltransferase inhibitors, DNMT1 inhibitors(DNA (cytosine-5)-methyltransferase 1 inhibitors), DNA methylation inhibitors

Therapeutic Areas

NeoplasmsHemic and Lymphatic DiseasesOther Diseases+ [8]

Active Indication

Acute Myeloid LeukemiaHereditary Leiomyomatosis and Renal Cell CancerParaganglioma+ [34]

Inactive Indication

Adenocarcinoma of large intestineAdult Acute Myeloblastic LeukemiaExtensive stage Small Cell Lung Cancer+ [12]

Originator Organization

SuperGen, Inc.

Active Organization

Otsuka Holdings Co., Ltd.

University of Michigan

The University of Texas MD Anderson Cancer Center

+ [12]

Inactive Organization

Columbia University

Astex Therapeutics Ltd.

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (United States)

Structure/Sequence

Molecular FormulaC18H24N9NaO10P

InChIKeyGIWNNMMDOVYUOT-BYKQGDNKSA-N

CAS Registry929904-85-8

Clinical Trials associated with Guadecitabine Sodium

NCT04340843

/ Active, not recruitingPhase 2IIT

A Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

This phase II trial studies the effect of belinostat and SGI-110 (guadecitabine) or ASTX727 in treating patients with conventional chondrosarcoma that cannot be removed by surgery (unresectable) and has spread from where it first started (primary site) to other places in the body (metastatic). Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as guadecitabine and ASTX727, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving belinostat in combination with guadecitabine or ASTX727 may lower the chance of unresectable and metastatic chondrosarcoma growing or spreading.

Start Date08 Sep 2020

Sponsor / Collaborator

National Cancer Institute

EUCTR2019-002986-36-IT

/ Not yet recruitingPhase 2IIT

A randomized, run-in, phase II study of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1 - NIBIT-ML-1

Start Date19 Jun 2020

Sponsor / Collaborator-

NCT04250246

/ Not yet recruitingPhase 2IIT

A Randomized, run-in, Multi-center, Phase II Study of Nivolumab Combined With Ipilimumab and Guadecitabine or Nivolumab Combined With Ipilimumab in Melanoma and NSCLC Patients Resistant to Anti-PD-1/PD-L1 (NIBIT-ML1)

This is a run-in, randomized, non-comparative, phase II study designed according to a two stages optimal design by Simon. This phase II design will be preceded by a safety evaluation after the first cohort of 6 patients to preserve a high-grade of overlapping and/or unexpected toxicity rate. The study will assess the immune-objective response rate (iORR) (assessed using iRECIST criteria) of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab, in Melanoma and non-small cell lung cancer (NSCLC) patients resistant to anti-PD-1/PD-L1 therapy. Immune biologic correlates to treatment will be assessed as exploratory endpoints.

Start Date01 Mar 2020

Sponsor / Collaborator

Bristol Myers Squibb Co.

[+1]

100 Clinical Results associated with Guadecitabine Sodium

100 Translational Medicine associated with Guadecitabine Sodium

100 Patents (Medical) associated with Guadecitabine Sodium

146

Literatures (Medical) associated with Guadecitabine Sodium

01 Feb 2025·LIFE SCIENCES

Hypomethylating agents as emerging therapeutics for triple-negative breast cancer

Review

Author: Mohd Redzwan, Norhanani ; Nik Amirah Auni, Nik Mohd Asri ; Yahya, Maya Mazuwin ; Fauzi, Agustine Nengsih ; Wong, Kah Keng

Triple-negative breast cancer (TNBC) is recognized as the most aggressive subtype of breast cancer. Epigenetic silencing, such as DNA methylation mediated by DNA methyltransferases (DNMTs) plays key roles in TNBC tumorigenesis. Hypomethylating agents (HMAs) such as azacitidine, decitabine, and guadecitabine are key inhibitors of DNMTs, and accumulating evidence has shown their immunogenicity properties. In this review, the efficacy and anti-tumor immune responses triggered by HMAs in TNBC are presented and discussed. Essentially, overexpression of DNMTs is associated with poor prognosis and reduced TNBC survival rates, and these effects are negated by HMAs. In particular, HMAs could reverse epigenetic silencing of tumor suppressor genes and enhance immune recognition of TNBC cells. Clinical trials of HMAs in TNBCs are limited but early-stage trials indicate that HMAs are safe and tolerable. More clinical studies are required to establish the effectiveness of HMAs against the disease, as supported by preclinical data substantiating their effectiveness especially guadecitabine. Future research should focus on optimizing dosing and exploring combinations with immunotherapies to maximize the potential of HMAs in TNBC treatment.

01 Sep 2024·Journal of biomolecular structure & dynamics

Exploring epigenetic drugs as potential inhibitors of SARS-CoV-2 main protease: a docking and MD simulation study.

Article

Author: Akkus, Ebru ; Kocak, Abdulkadir ; Uzuner, Ugur ; Çelik Uzuner, Selcen

The COVID-19 pandemic has caused havoc around the globe since 2019 and is considered the largest global epidemic of the twentieth century. Although the first antiviral drug, Remdesivir, was initially introduced against COVID‑19, virtually no tangible therapeutic drugs exist to treat SARS-CoV-2 infection. FDA-approved Paxlovid (Nirmatrelvir supplemented by Ritonavir) was recently announced as a promising drug against the SARS-CoV-2 major protease (M^pro). Here we report for the first time the remarkable inhibitory potentials of lead epigenetic-targeting drugs (epi-drugs) against SARS-CoV-2 M^pro. Epi-drugs are promising compounds to be used in combination with cancer chemotherapeutics to regulate gene expression. The search for all known epi-drugs for the specific inhibition of SARS-CoV-2 M^pro was performed for the first time by consensus (three high-order program) molecular docking studies and end-state free energy calculations. Several epi-drugs were identified with highly comparable binding affinity to SARS-CoV-2 M^pro compared to Nirmatrelvir. In particular, potent histone methyltransferase inhibitor EPZ005687 and DNA methyltransferase inhibitor Guadecitabine were prominent as the most promising epi-drug inhibitors for SARS-CoV-2 M^pro. Long Molecular dynamics (MD) simulations (200 ns each) and corresponding MM-GBSA calculations confirmed the stability of the EPZ005687-M^pro complex with MM-GBSA binding free energy (ΔG_bind) -48.2 kcal/mol (EPZ005687) compared to Nirmatrelvir (-44.7 kcal/mol). Taken together, the antiviral activities of the highlighted epi-drugs are reported beyond widespread use in combination with anti-cancer agents. The current findings therefore highlight as yet unexplored antiviral potential of epi-drugs suitable for use in patients struggling with chronic immunosuppressive disorders.Communicated by Ramaswamy H. Sarma.

15 May 2024·International journal of cancer

A phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS‐102 in irinotecan‐refractory metastatic colorectal cancer patients

Article

Author: Jones, Peter ; Baylin, Stephen ; Azad, Nilofer S ; Rami, Vandna ; Cope, Leslie ; Gootjes, Elske ; Lenz, Heinz Josef ; Lee, Valerie ; Zahurak, Marianna ; Iqbal, Syma ; Verheul, Henk ; Ahuja, Nita ; Parkinson, Rose ; Cercek, Andrea ; El Khoueiry, Anthony

Abstract:

DNA methyltransferase inhibitors (DNMTi) have demonstrated benefit in reversing resistance to systemic therapies for several cancer types. In a phase II trial of guadecitabine and irinotecan compared to regorafenib or TAS‐102 in pts with advanced mCRC refractory to irinotecan. Patients with mCRC refractory to irinotecan were randomized 2:1 to guadecitabine and irinotecan (Arm A) vs standard of care regorafenib or TAS‐102 (Arm B) on a 28‐day cycle. Between January 15, 2016 and October 24, 2018, 104 pts were randomized at four international sites, with 96 pts undergoing treatment, 62 in Arm A and 34 in Arm B. Median overall survival was 7.15 months for Arm A and 7.66 months for Arm B (HR 0.93, 95% CI: 0.58–1.47, P = .75). The Kaplan–Meier rates of progression free survival at 4 months were 32% in Arm A and 26% in Arm B. Common ≥Grade 3 treatment related adverse events in Arm A were neutropenia (42%), anemia (18%), diarrhea (11%), compared to Arm B pts with neutropenia (12%), anemia (12%). Guadecitabine and irinotecan had similar OS compared to standard of care TAS‐102 or regorafenib, with evidence of target modulation. Clinical trial information: NCT01896856.

News (Medical) associated with Guadecitabine Sodium

12 Apr 2021

·www.globenewswire.com

Global Acute Myeloid Leukemia (AML) Disease Analysis Report 2021: On Average, it Takes 10.8 Years from Phase I to Approval, Compared to 9.6 Years in the Overall Oncology Space

Dublin, April 12, 2021 (GLOBE NEWSWIRE) -- The "Disease Analysis: Acute Myeloid Leukemia (AML)" report has been added to ResearchAndMarkets.com's offering. AML is a type of heterogeneous hematological malignancy that originates from immature white blood cells (blasts) in the bone marrow, which may be derived from either a hematopoietic stem cell or a lineage-specific progenitor cell. "Acute" means that the leukemia may progress rapidly - AML generally spreads quickly to the bloodstream and can then spread to other parts of the body including the lymph nodes, spleen, central nervous system, and testicles.Latest Key TakeawaysThe publisher estimates that in 2018, there were 158,400 incident cases of acute myeloid leukemia (AML) worldwide and expects that number to increase to 169,000 incident cases by 2027. Approximately 60% of newly diagnosed patients are eligible for intensive chemotherapy, such as the 7+3 regimen of cytarabine and daunorubicin.Since 2017, there have been nine new drugs approved for AML in the US, dramatically changing the treatment landscape. Gone is the era where all front-line patients received either 7+3 chemotherapy or a hypomethylating agent (decitabine or azacitidine). Many of the new therapies target specific segments of AML or patients with specific mutations. As such, there is currently little competition between the new therapies, but that will change as therapies receive label expansions and new competitor therapies are approved.Two FLT3 inhibitors have been approved for FLT3-mutated AML: Rydapt for front-line patients eligible for intensive chemotherapy, and Xospata for relapsed/refractory patients. Rydapt may soon face competition in the front-line FLT3 setting as quizartinib, crenolanib, and Xospata are being evaluated in combination with standard chemotherapy and as single-agent maintenance therapies following either chemotherapy consolidation or hematopoietic stem cell transplant (HSCT). Approval in the lucrative maintenance setting would give these drugs a favorable long-term commercial outlook. Approximately 25-30% of AML patients have an FLT3 mutation.Tibsovo and Idhifa are approved in the US as oral, single-agent therapies for relapsed/refractory AML patients with IDH1 and IDH2 mutations, respectively. Tibsovo is also approved as a monotherapy for front-line patients over the age of 75 years. Both of these IDH inhibitors are now in Phase III trials in combination with standard induction (7+3) and consolidation chemotherapy and as maintenance therapy in front-line AML. Tibsovo is also being investigated in combination with azacitidine in a Phase III trial in front-line patients. Approval of Tibsovo and Idhifa in the EU will depend on these Phase III results. Tibsovo may face competition from FT-2102, an IDH1 inhibitor being evaluated in the relapsed/refractory setting in a pivotal single-arm Phase II trial. IDH1 mutations are present in 6-9% of AML, while IDH2 mutations are present in approximately 12% of cases.Mylotarg, an antibody-drug conjugate targeting CD33, is the only monoclonal antibody therapy approved for AML. Mylotarg combined with intensive chemotherapy is recommended for newly diagnosed patients with favorable cytogenetic risk (approximately 10% of patients eligible for intensive chemotherapy). Over 90% of AML patients are positive for CD33 expression.Vyxeos, a liposomal formulation of the 7+3 chemotherapy regimen, was approved in the US and EU for the treatment of newly diagnosed patients with secondary AML after showing an improvement in overall survival compared to the 7+3 regimen in patients ?60 years of age. Secondary AML accounts for approximately one third of new AML diagnoses, but most of these patients will be too frail for Vyxeos. Approximately 16% of patients eligible for intensive chemotherapy have secondary AML. Market access for Vyxeos is strengthened by positive recommendations from the US Centers for Medicare and Medicaid Services and from NICE in England and Wales.Venclexta combined with azacitidine is the new standard of care for newly diagnosed AML patients not suited for intensive chemotherapy (approximately 40% of newly diagnosed patients). A confirmatory Phase III trial evaluating Venclexta + azacitidine demonstrated a survival advantage (15 months versus 10 months) and supported regulatory submissions to European and Japanese authorities, with approvals expected in 2021. Venclexta is currently being evaluated in combination with novel agents in several trials, and a Phase III study (VIALE-M) is evaluating Venclexta combined with azacitidine as maintenance therapy for AML patients in first remission after conventional chemotherapy.Daurismo is the first and only Hedgehog pathway inhibitor approved for AML. Daurismo is approved in combination with low-dose cytarabine (LDAC) for newly diagnosed AML patients not suited for intensive chemotherapy, and will compete with Venclexta in this difficult-to-treat setting. However, in the US, hypomethylating agents are preferred over LDAC, so Venclexta may be preferred over Daurismo.Onureg, an oral formulation of azacitidine, increased overall survival and relapse-free survival in a Phase III trial and was approved in the US as a maintenance therapy following intensive chemotherapy for patients not suited for an HSCT. A European approval decision is expected in mid-2021. The maintenance setting would be a new setting for Vidaza (azacitidine) which is currently used in the EU (and off-label in the US) to treat newly diagnosed elderly AML patients.Rafael Pharmaceuticals is developing devimistat (CPI-613) as a first-in-class therapeutic targeting the altered mitochondrial metabolism present in many cancers, including AML. Devimistat's outlook will depend on the efficacy and safety results from a Phase III trial evaluating the drug in combination with high-dose cytarabine and mitoxantrone in relapsed/refractory AML patients. The first interim analysis is expected in Q2 2021.Chimerix's dociparstat sodium (DSTAT), a glycosaminoglycan analog of heparin designed to have reduced anticoagulant effects, targets the CXCR4 pathway which is involved in the homing and adhesion of AML cells to the bone marrow and is associated with resistance to systemic drugs. DSTAT is being developed in combination with intensive 7+3 chemotherapy for newly diagnosed AML, with the aim of improving the rate of durable response. A Phase III trial is enrolling patients with intermediate or unfavorable cytogenetic risk (74% of patients eligible for intensive chemotherapy).Otsuka's Inqovi is an oral formulation of decitabine that is being developed for patients with AML unsuited for intensive induction chemotherapy. In ASCERTAIN, a Phase III trial enrolling patients with MDS, Inqovi met the trial's primary endpoint of demonstrating pharmacokinetic equivalence to intravenous decitabine. ASCERTAIN has now been extended to include patients with AML in the EU, but a trial with efficacy endpoints will be needed to secure a US AML approval.Takeda's pevonedistat targets the NEDD8-activating enzyme in the ubiquitin-proteasome pathway, and is being developed in combination with azacitidine for a subpopulation of newly diagnosed, elderly AML patients categorized as low-blast count AML. Pevonedistat is also being evaluated in a randomized Phase II trial in combination with Venclexta and azacitidine in newly diagnosed AML patients unfit for intensive chemotherapy.Zeltherva is a therapeutic vaccine being developed as maintenance therapy for patients who have achieved hematologic complete remission, with or without thrombocytopenia, after second-line therapy and who are ineligible for allogeneic stem cell transplantation. Zeltherva's outlook in the specialized setting of CR2 will depend on results in REGAL, its Phase III trial. An interim analysis for safety and futility is expected in Q4 2021.Not including FLT3 and IDH inhibitors, there are five drugs in late-phase development for newly diagnosed AML patients. Dociparstat sodium and entospletinib are being developed in combination with intensive chemotherapy, while MBG453, pevonedistat, and Inqovi are being developed for elderly patients.Relapsed/refractory AML remains an area of unmet need, and new therapies are being developed. Not including FLT3 or IDH inhibitors, there are currently five late-stage therapies being evaluated for this setting (devimistat, DFP-10917, flotetuzumab, Iomab-B, and uproleselan).Key recent events include the approval of Onureg and presentation of numerical data from Venclexta's VIALE-A trial. There were Phase III failures for Helsinn's pracinostat combined with azacitidine in the newly diagnosed setting and for Roche's idasanutlin and Otsuka's guadecitabine in the relapsed/refractory setting. Other Phase III failures include trials evaluting Xospata combined with azacitidine and Daurismo combined with intensive chemotherapy in front-line AML, and an Idhifa monotherapy trial in the third- and fourth-line setting.Key upcoming catalysts for 2021 include topline results from Phase III trials for devimistat, Iomab-B, uproleselan, and Zeltherva, and a possible NDA submission for FT-2102.The overall likelihood of approval of a Phase I AML asset is 6.3%, and the average probability a drug advances from Phase III is 50%. AML drugs, on average, take 10.8 years from Phase I to approval, compared to 9.6 years in the overall oncology space. Companies Mentioned For more information about this report visit

AntibodyFirst in ClassVaccineADC

07 Jun 2019

·www.biospace.com

Astex Pharma and Otsuka’s Cancer Trial Meets Primary Endpoints

The fixed-dose combination was being evaluated in adults with intermediate and high-risk myelodysplastic syndrome and chronic myelomonocytic leukemia. Astex Pharmaceuticals , which is a member of the Otsuka group, and Otsuka Pharmaceutical announced that their ASCERTAIN Phase III clinical trial of cedazuridine and decitabine (ASTX727) compared to decitabine IV alone hit its primary endpoints. The fixed-dose combination was being evaluated in adults with intermediate and high-risk myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). The primary endpoint was decitabine exposure equivalence of five-day dosing between oral doses of the combination and the IV dose of decitabine. The company plans to submit a New Drug Application (NDA) for the combination therapy with the U.S. Food and Drug Administration (FDA) by the end of the year. “We are delighted with the outcome of the ASCERTAIN trial, and the demonstration that the fixed dose combination of cedazuridine with decitabine enables successful oral delivery of decitabine, alleviating the significant burden of five days of monthly IV infusions for patients who may continue to benefit from the drug for several months or even years,” stated Mohammad Azab, Astex’s president and chief medical officer. He added, “Subject to regulatory review and approvals, ASTX727 could bring a new treatment option to patients with these deadly diseases. We are extremely grateful to all the patients, caregivers, partner research and manufacturing organizations, as well as the healthcare professionals who contributed to this effort.” ASTX727 had been studied in a Phase I/II trial to determine appropriate doses for each component of the combination to determine that the decitabine dose in the oral formula is equivalent to that in IV decitabine at the approved daily dose of a one-hour infusion at 20 mg/m 2 . Also today, Taiho Oncology reported it has taken on commercialization responsibility from Otsuka Pharma for ASTX727, as well as guadecitabine (SGI-110) in the U.S. and Canada. Taiho Pharma Canada will commercialize them in Canada. “This commercialization agreement is highly significant for Taiho Oncology as it allows us to build on the long-term strategy of expanding our presence in North America,” stated Timothy Whitten, Taiho’s chief executive officer. “These investigational therapies have the potential to provide physicians and patients with much-needed treatment options for a range of hematologic malignancies. We look forward to working with Astex as we bring these compounds to market.” Astex is also currently conducting clinical trials with guadecitabine in relapsed and refractory acute myeloid leukemia (R/R AML) and relapsed and refractory myelodysplastic syndrome (R/R MDS) and CMML. Cedazuridine is a cytidine deaminase inhibitor, while decitabine is a DNA hypomethylating agent. ASTX727 inhibits cytidine deaminase in the gut and liver, which allows for the oral delivery of cedazuridine. Guadecitabine (SGI-110) is a DNA methyltransferase (DNMT) inhibitor. It was designed to be resistant to degradation by cytidine deaminase with the intention of increasing the exposure time of the active metabolite, decitabine, to cancer cells. That would allow decitabine to be absorbed in larger amounts by rapidly dividing cancer cells. It is being studied in combination with carboplatin to treat platinum-resistant ovarian cancer, in liver cancer after failure of Nexavar (sorafenib) and in combination with irinotecan for colorectal cancer.

NDAPhase 3License out/in

31 Jul 2018

·www.biospace.com

Astex Pharma’s Leukemia Drug Fails Clinical Trial

Astex Pharmaceuticals, a member of the Otsuka group of companies, and Otsuka Pharmaceutical, indicated their guadecitabine (SGI-110) missed its co-primary endpoints in acute myeloid leukemia (AML). Astex Pharmaceuticals , a member of the Otsuka group of companies, and Otsuka Pharmaceutical , indicated their guadecitabine (SGI-110) missed its co-primary endpoints in acute myeloid leukemia (AML). The companies announced topline results from the ASTRAL-1 clinical trial that looked at the efficacy and safety of guadecitabine in adults with previously untreated AML who were not eligible for intensive induction chemotherapy. It failed to meet its co-primary endpoints of complete response (CR) rate and overall survival (OS) compared to the control arm of physician’s pick of azacytidine, decitabine, or low dose cytarabine. The evaluation of secondary endpoints is still ongoing. “We are disappointed in the outcome of the ASTRA-1 study,” said Mohammad Azab, Astex’s president and chief medical officer, in a statement. “The study used very strict criteria of ineligibility to receive intensive chemotherapy based on age (over 75 years) or poor performance status (ECOG PS of 2 or 3) or comorbidities, which made it a difficult population to show superior benefit of guadecitabine. ASTRAL-1 is the largest global prospective study ever conducted in this specific patient population with low intensity therapy, with 815 patients randomized, of whom about 90 percent were treated with hypomethylating agents or HMAs (guadecitabine, azacytidine, or decitabine). The large body of clinical and genetic data will still provide the medical community with very valuable insights into the role of several prognostic clinical and genetic markers that may influence outcome with HMA treatment.” Astex will continue to focus on its ongoing Phase III ASTRAL-2 and ASTRAL-3 clinical trials looking at guadecitabine in relapsed and refractory AML and relapsed and refractory MDS and CMML. Guadecitabine is a next-generation DNA hypomethylating agent. It was designed to resist degradation by cytidine deaminase, which prolongs the exposure of cancer cells to decitabine, the active ingredient. This is designed to increase uptake of decitabine into the DNA of rapidly dividing cancer cells. In March, Astex announced that its pharmaceutical partner, Belgium-based Janssen Pharmaceutica , a Johnson & Johnson company, had been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for erdafitinib for metastatic urothelial cancer. The drug had been discovered by the two companies as part of a 2008 collaboration and license deal to identify novel, small molecule inhibitors of Fibroblast Growth Factor Receptor (FGFR) kinase, including for treating cancer. Janssen handled clinical development and commercialization of any products that came out of the collaboration. Urothelial cancer, especially of the bladder, is the sixth most common type of cancer in the U.S. The Breakthrough Therapy Designation was granted based on positive data from a multicenter, open-label Phase II clinical trial. “This is a great endorsement of our scientific approach and our team,” said Harren Jhoti, president and chief executive officer of Astex, UK, in a statement. “Astex is committed to the fight against cancer and so is delighted that erdafitinib has been granted Breakthrough Therapy Designation by the US FDA. Congratulations to our valued collaborators at Janssen for their excellent work in advancing erdafitinib to this exciting stage in this development.”

Clinical ResultPhase 3Phase 2Breakthrough TherapyLicense out/in

100 Deals associated with Guadecitabine Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D10809	-	-	DB11918

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Myelomonocytic Leukemia	Phase 3	United States	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	Japan	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	Belgium	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	Canada	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	Czechia	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	Denmark	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	France	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	Germany	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	Italy	Astex Pharmaceuticals, Inc.	13 Jan 2017
Chronic Myelomonocytic Leukemia	Phase 3	Poland	Astex Pharmaceuticals, Inc.	13 Jan 2017

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01896856 (Pubmed) Manual	Phase 2	Metastatic Colorectal Carcinoma	96	Guadecitabine anirinotecanan	jlblsliweo(ldjnfbftpv) = Common ≥Grade 3 treatment related adverse events in Arm A were neutropenia (42%), anemia (18%), diarrhea (11%), compared to Arm B pts with neutropenia (12%), anemia (12%). gyssdupxhc (zmolnsacmk ) View more	Positive	15 May 2024
				Regorafenib or TAS-102
NCT02920008 (ASTRAL-2, Pubmed) Manual	Phase 3	Acute Myeloid Leukemia	302	Guadecitabine	awjfefpyxi(jlieloekmu) = tjtdunwvub sguayyogrv (bxyjigfvly ) View more	Negative	17 Jan 2024
				Guadecitabine (Preselected treatment choice (TC))	awjfefpyxi(jlieloekmu) = bgowgrkdez sguayyogrv (bxyjigfvly ) View more
NCT03913455 (CTgov)	Phase 2	Extensive stage Small Cell Lung Cancer	24	Carboplatin+Guadecitabine	mhpvxkxykb = zqacwzdjwd zggarfqlea (zgxcjmzinp, zchfumlrxx - hmxaiwwbuy) View more	-	20 Dec 2023
ASH2023	Phase 1/2	Chronic Myelomonocytic Leukemia \| Refractory Myelodysplastic Syndrome \| Recurrent Myelodysplastic Syndrome	27	Guadecitabine and Atezolizumab	wxhmxzvoru(odzxxchpbm) = mmeqgkyewy xdeatkhwkp (fusardbpwu )	-	09 Dec 2023
NCT02348489 (Pubmed)	Phase 3	Acute Myeloid Leukemia	815	Guadecitabine	fjlljzvmgi(dcwupwfayz) = ypcqewyphe eienrmjhut (sftzmdflka ) View more	Negative	05 Jun 2023
				Treatment Choice (Azacitidine, Decitabine, or Low-dose Cytarabine)	fjlljzvmgi(dcwupwfayz) = rvbtaronmo eienrmjhut (sftzmdflka ) View more
NCT04340843 (ETCTN/NCI 10330, ASCO2023) Manual	Phase 2	Chondrosarcoma IDH1/2 mutations	19	Belinostat + SGI-110	dhsnconzwp(cdgkfmwoky) = There were no objective responses girqbiziig (hmnfwttrws ) View more	Positive	31 May 2023
				Belinostat + ASTX727
NCT02920008 (ASTRAL-2, CTgov)	Phase 3	Acute Myeloid Leukemia	302	guadecitabine (Guadecitabine)	vooehgjzza(ffwovjaupt) = trovwvpndl hwktiypmlh (yuhenjjlyj, vidwuwijlq - ysagltwwro) View more	-	25 May 2023
				Treatment Choice (TC) (Treatment Choice (TC))	vooehgjzza(ffwovjaupt) = iueuqeirvw hwktiypmlh (yuhenjjlyj, ypikxejkyh - jjhpahqqys) View more
NCT02907359 (ASTRAL-3, CTgov)	Phase 3	Chronic Myelomonocytic Leukemia \| Myelodysplastic Syndromes	417	Guadecitabine (Guadecitabine)	zrmssjyded(ahrggyzpxw) = nvxnwlxrkh rquzqhndob (fkgigdxtai, trvitnijek - jaixqkkipp) View more	-	18 May 2023
				Treatment Choice (Treatment Choice)	zrmssjyded(ahrggyzpxw) = svisisngof rquzqhndob (fkgigdxtai, mpgwkvtnrr - uznrkkmzac) View more
NCT03603964 (CTgov)	Phase 2	Acute Myeloid Leukemia	35	Guadecitabine	eknerksdgx = mocnnpszby ktagmzbuzc (lomtetthxo, urjhbvhvyf - uywgxoxllp) View more	-	26 Apr 2023
NCT02608437 (NIBIT-M4, AACR2023)	Not Applicable	Unresectable Melanoma	-	Guadecitabine plus ipilimumab	xwhohbahkf(vvamjdncnq) = ybwkfxocps xxhttqpjnq (hebefprige ) View more	-	04 Apr 2023

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Guadecitabine Sodium

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