[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Taiho Oncology, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":176},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,82,98,121,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100513608","phase-2-a-study-of-zipalertinib-in-patients-with-advanced-non-small-cell-lung-cancer-with-epidermal-growth-factor-receptor-egfr-exon-20-insertions-or-other-uncommon-mutation-100513608",false,"NCT05967689","A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.","An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon\u002FSingle or Compound Epidermal Growth Factor Receptor Mutations.","REZILIENT2","Inclusion Criteria:\n\n1. Written informed consent.\n2. ≥18 years of age (or meets the country's regulatory definition of legal adult age, whichever is greater.\n3. Pathologically confirmed, locally advanced or metastatic NSCLC meeting all the following criteria:\n\n   Cohort A participants:\n   * Documented EGFR ex20ins status, as determined by local testing performed at a Clinical Laboratory Improvement Amendments (CLIA) certified (United States \\[US\\]) or locally certified laboratory (outside the US).\n   * Progressed on or after systemic therapy with an agent targeting ex20ins, either alone or in combination with standard platinum-based chemotherapy for the treatment of advanced disease. Participants who discontinued previous treatment due to unacceptable toxicity are eligible.\n\n     i. Permitted prior ex20ins therapies include: amivantamab, sunvozertinib (DZD9008), and BLU451. Other prior ex20ins--directed treatment may be discussed with the Sponsor for eligibility assessment.\n   * Participants with brain metastasis must be neurologically stable. Participants must have received central nervous system (CNS)-directed therapy and have no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\] scan) during the Screening Period. Additionally, they must be on a stable or decreasing dose of corticosteroids and\u002For anti-convulsant medications for at least 2 weeks prior to the first dose of study treatment. Participants with a history of uncontrolled seizures or LMD are not eligible.\n\n   Cohort B participants:\n   * Documented EGFR ex20instatus, as determined by local testing performed at a CLIA-certified (US) or locally certified laboratory (outside the US).\n   * Participants who have not received prior treatment for advanced or metastatic disease and who are not appropriate candidates for first-line doublet platinum-based chemotherapy based on Investigator judgment or has refused first-line doublet platinum-based chemotherapy following discussion with the Investigator. Prior adjuvant\u002Fneoadjuvant treatment for early-stage disease must have been completed \\>6 months prior to the first dose of study treatment.\n   * Participants with brain metastasis must be neurologically stable. Participants must have received CNS-directed therapy and have no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the Screening Period, and they must be on a stable or decreasing dose of corticosteroids and\u002For anti-convulsant medications for at least 2 weeks prior to the first dose of study treatment. Participants with history of uncontrolled seizures or LMD are not eligible.\n\n   Cohort C participants:\n   * Documented ex20ins or other uncommon single or compound EGFR non-ex20ins status, as determined by local testing performed at a CLIA-certified (US) or locally certified laboratory (outside the US).\n   * Presence of brain metastasis(es) characterized as at least one of the following:\n\n     * Newly diagnosed and\u002For progressive brain metastasis(es) measurable by Response Assessment in Neuro-oncology Brain Metastases (RANO-BM) criteria and not subjected to CNS-directed therapy, AND\u002FOR\n     * LMD measurable or non-measurable by RANO-BM criteria and confirmed by a positive cerebrospinal fluid cytology, or unequivocal radiographic and\u002For clinical determination.\n   * Participants may not require other immediate CNS-directed therapy or will likely require other CNS directed anti-tumor therapy during the first cycle of study treatment, as judged by the Investigator.\n\n   Cohort D participants:\n   * Documented other uncommon single or compound EGFR non-ex20ins status (excluding C797S), as determined by local testing performed at a CLIA certified (US) or locally certified laboratory (outside the US). A list of eligible mutations will be provided in a separate document.\n   * Participants with brain metastasis must be neurologically stable. Participants must have received CNS-directed therapy and have no evidence of progression for at least 4 weeks after CNS- directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the Screening Period, and they must be on a stable or decreasing dose of corticosteroids and\u002For anti-convulsant medications for at least 2 weeks prior to the first dose of study treatment. Participants with history of uncontrolled seizures or LMD are not eligible.\n   * Participants who have not received prior systemic therapy for their locally advanced or metastatic NSCLC disease.\n   * Prior adjuvant\u002Fneoadjuvant treatment for early-stage disease must have been completed \\>6 months prior to the first dose of study treatment. Participants may not have received prior adjuvant\u002Fneoadjuvant treatment with any EGFR tyrosine kinase inhibitor (TKI).\n4. Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).\n5. Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers (details provided in a laboratory manual). Participants with insufficient tissue may be eligible following discussion with the Sponsor.\n6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 17.\n7. Adequate organ function, as defined by the hematologic, renal and hepatic laboratory values.\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to administration of the first dose of study treatment. Female participants are not considered to be of childbearing potential if they are post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).\n9. Both males and females of reproductive potential must agree to use effective birth control during the study prior to the first dose of study drug and for 1 month after the last dose of study treatment.\n\nDDI Substudy:\n\n1. Participant has pathologically confirmed, locally advanced or metastatic NSCLC:\n\n   a. Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendments (CLIA) certified (US) or locally certified laboratory (outside of the US) local laboratory, defined as either one of the following EGFRmts:\n   * ex20ins EGFRmt OR\n   * other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) OR\n   * common EGFRmt (eg, ex19del or L858R)\n2. Participant has progressed on or after receiving prior standard of care (SoC) systemic therapy for their locally advanced or metastatic NSCLC disease unless:\n\n   * Participant for whom no approved therapy with demonstrated clinical benefit is indicated or available,\n   * Participant is intolerant to the available first-line (1L) SoC treatment options, OR\n   * Participant has refused 1L SoC treatment options (after being appropriately informed of the treatment options, risks, and benefits).\n3. Participants with brain metastasis are eligible if they fulfill all of the criteria below:\n\n   * Have received CNS-directed therapy and have no evidence of progression for at least 4 weeks after CNS- directed treatment, as ascertained by brain imaging (MRI or CT scan) during the Screening Period,\n   * Are on a stable or decreasing dose of corticosteroids and\u002For anti-convulsant medications for at least 2 weeks prior to the first dose of study treatment,\n   * Are neurologically stable with no history of uncontrolled seizures.\n4. ECOG PS of 0 or 1.\n\nDose Optimization Substudy:\n\n1. Has pathologically confirmed, locally advanced or metastatic NSCLC meeting all the following criteria:\n\n   1. Documented EGFR ex20ins status, as determined by local testing performed at a CLIA certified (US) or locally certified laboratory (outside the US)\n   2. Progressed on or after systemic therapy standard platinum-based chemotherapy for the treatment of advanced disease. Participants who discontinued previous treatment due to unacceptable toxicity are eligible.\n\n   Note: Progression on or after systemic therapy with amivantamab is permitted (eg, given as monotherapy or in combination with chemotherapy).\n2. Participants with CNS metastases are eligible if both of the following criteria are met:\n\n   i. Measurable lesions according to RANO-BM defined as a contrast-enhancing lesion that can be accurately measured in at least one dimension, with a minimum size of 10 millimeters (mm), or at least 5 mm if MRI slice thickness is ≤ 1.5 mm ii. Previously received definitive local treatment and have stable CNS disease (defined as being neurologically stable and off corticosteroid for at least 2 weeks prior to enrollment) OR Asymptomatic CNS metastases ≤ 2 cm in size if, in the opinion of the investigator, immediate definitive treatment is not indicated.\n3. Measurable disease per RECIST 1.1.\n4. Has archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers\n5. ECOG PS of 0 or 1.\n6. Has adequate organ function.\n\nExclusion Criteria:\n\n1. Participant is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged to be scientifically or medically incompatible with this study.\n2. Has received any of the following within the specific time frame specified:\n\n   1. Participant has received Zipalertinib (TAS6417\u002FCLN081) at any time\n   2. CNS radiotherapy (gamma knife radiotherapy is allowed) ≤ 12 weeks, thoracic radiotherapy ≤ 28 days, or other palliative radiation ≤ 14 days prior to the first dose of study\n   3. Anticancer immunotherapy ≤28 days prior to the first dose of study treatment\n   4. Major surgery (excluding placement of vascular access) ≤28 days prior to the first dose of study treatment.\n   5. Any prior treatment with an EGFR exon20ins- targeted TKI\n   6. Participants with leptomeningeal CNS disease.\n3. Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment, except for Grade 2 alopecia or skin pigmentation. Participants with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.\n4. Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or evidence of clinically active interstitial lung disease.\n5. Impaired cardiac function or clinically significant cardiac disease including any of the following:\n\n   1. History of congestive heart failure (CHF) Class III\u002FIV according to the New York Heart Association (NYHA) Functional Classification.\n   2. Serious cardiac arrhythmias requiring treatment.\n   3. Resting corrected QT interval (QTc) \\>470 msec using Fridericia's formula (QTcF).\n6. Is unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal absorption of zipalertinib (eg, inflammatory bowel disease, malabsorption syndrome, or prior gastric\u002Fbowel resection).\n7. History of another primary malignancy ≤2 years prior to the date of first dose of study treatment unless at least one of the following criteria are met:\n\n   1. Adequately treated basal or squamous cell carcinoma of the skin\n   2. Cancer in situ of the breast or cervix\n   3. Participants with previously treated malignancy if all treatment for that malignancy was completed at least 2 years prior to first dose and no evidence of disease\n   4. Participants with concurrent malignancy clinically stable and not requiring tumor-directed treatment\n8. Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is not controlled with treatment.\n9. History of Coronavirus disease 2019 (COVID-19) infection within 4 weeks prior to enrollment and\u002For has persistent clinically significant pulmonary symptoms related to prior COVID-19 infection.\n10. Active bleeding disorders.\n11. Known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class.\n12. Is pregnant, lactating, or planning to become pregnant.\n13. The participant is, in the Investigator's opinion, unable or unwilling to comply with the trial procedures.","ALL","18 Years",{"count":20,"type":21},220,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.",[27],"Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations",[29,30,31,32,33,34,35,36,37],"NSCLC","Carcinoma","Non-Small Cell Lung","Lung disease","locally advanced\u002F metastatic","ex20ins mutation","Insertion Mutations","EGFR uncommon\u002F single mutation Phase 2, Phase 2b, Phase II Exon 20","TAS6417\u002F CLN-081","RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":42},"2023-07-31",{"date":46,"type":21},"2028-12-31",{"name":48,"class":49},"Taiho Oncology, Inc.","INDUSTRY",80,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100495130","phase-2-study-of-futibatinib-in-patients-with-advanced-cholangiocarcinoma-with-fgfr2-fusion-or-rearrangement-100495130","NCT05727176","Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement","Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements","FOENIX-CCA4","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.\n2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement\n3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA\n4. Documentation of radiographic disease progression on the most recent prior therapy\n5. Measurable disease\n6. performance status 0 or 1\n7. Adequate organ function\n\nExclusion Criteria:\n\n1. History or current evidence of calcium and phosphate homeostasis disorder\n2. Current evidence of clinically significant retinal disorder\n3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:\n\n   1. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks\n   2. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks\n   3. Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer\n   4. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.\n   5. Patients with prior FGFR-directed therapy\n4. A serious illness or medical condition(s) including (but not limited to) the following:\n\n   1. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month\n   2. Known acute systemic infection\n   3. Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV New York Heart Association \\[NYHA\\] Classification) within the previous 2 months; if \\>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms\n   4. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.\n   5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study.\n5. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.\n6. Pregnant or lactating female.\n7. Known hypersensitivity or severe reaction to futibatinib or its excipients.",{"count":60,"type":21},120,[24],"This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.",[64,65,66],"Advanced Cholangiocarcinoma","FGFR2 Fusions","Gene Rearrangement",[68,69,70,71,72,73,74],"Futibatinib","Advanced cholangiocarcinoma","cholangiocarcinoma","FGFR2","Fusion","Rearrangemen","TAS-120",{"date":41,"type":42},{"date":77,"type":42},"2023-07-05",{"date":79,"type":21},"2026-12",{"name":48,"class":49},65,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":97,"locationsCount":4},"100642310","an-eap-treatment-protocol-of-zipalertinib-100642310","NCT07601399","An EAP Treatment Protocol of Zipalertinib","An Open-Label Expanded Access Program of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations Whose Disease Has Progressed on or After Platinum-Based Chemotherapy With or Without Amivantamab","Inclusion Criteria:\n\n1. Has provided written informed consent.\n2. Has histologically confirmed, locally advanced, metastatic, or recurrent unresectable NSCLC with EGFR ex20ins mutations based on testing performed by a qualified (CLIA certified) laboratory.\n\n4\\. Has measurable or nonmeasurable lesion(s). 5. Has progressed on or after platinum-based chemotherapy with or without amivantamab.\n\n6\\. Has progressed on available standard therapy or is unable to tolerate such standard therapy.\n\n7\\. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.\n\n8\\. Has adequate organ function. 9. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test prior to administration of the first dose of zipalertinib.\n\n10\\. Both males and females of reproductive potential must agree to use effective birth control during the program prior to the first dose of zipalertinib and for 1 week after the last dose of zipalertinib.\n\n11\\. Is able to take medications orally (feeding tube is not permitted).\n\nExclusion Criteria:\n\n1. Has a history and\u002For current evidence of any of the following:\n\n   * Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or evidence of clinically active interstitial lung disease\n   * Impaired cardiac function or clinically significant cardiac disease including any of the following:\n\n     1. History of congestive heart failure Class III\u002FIV according to the New York Heart Association Functional Classification\n     2. Serious cardiac arrhythmias requiring treatment\n   * Use of zipalertinib (TAS6417\u002FCLN-081) at any time.\n2. Has not recovered from side effects of the following prior therapies:\n\n   * Have any unresolved toxicity of Grade ≥ 2 from previous anticancer treatment, except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the treatment physician and Sponsor.\n   * Thoracic radiotherapy ≤ 28 days or palliative radiation (gamma knife radiotherapy is allowed) ≤ 14 days prior to the first dose of zipalertinib\n   * Anticancer immunotherapy ≤ 28 days prior to the first dose of zipalertinib\n   * Major surgery (excluding placement of vascular access) ≤ 28 days prior to the first dose of zipalertinib.\n3. Has a serious illness or medical condition(s) that in the judgment of the treating physician would make the patient inappropriate for entry into this program.\n4. Has a history of another primary malignancy whose natural history or treatment has the potential to interfere with the safety assessment of zipalertinib in the opinion of the treating physician.\n5. Has known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class.\n6. Is pregnant, lactating, or planning to become pregnant.","EXPANDED_ACCESS","\"Only licensed physicians may submit an email inquiry\u002Fquestion about Taiho's Zipalertinib Expanded Access Program via email (Zipalertinib@parexel.com). If you are a patient or caregiver, do not email Parexel or Taiho. Please talk to your physician. Do not share any patient Personally Identifiable Information with Parexel.\"\n\nThe objective of the study is to provide access to zipalertinib to patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy with or without amivantamab.",[92],"Non-Small Cell Lung Cancer","AVAILABLE","2026-06-09",{"date":96,"type":42},"2026-06-11",{"name":48,"class":49},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":120},"100435721","phase-1-study-to-evaluate-the-pharmacokinetics-and-safety-of-oral-decitabine-and-cedazuridine-in-cancer-patients-with-hepatic-impairment-100435721","NCT04953910","Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment","A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Moderate and Severe Hepatic Impairment","Inclusion Criteria:\n\n* Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment cycle.\n* Participants must have a histologically or cytologically confirmed malignancy as follows:\n\n  1. A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available.\n\n     or\n  2. AML or MDS. or\n  3. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available.\n* For participants with AML\u002FMDS only:\n\n  1. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification; or\n  2. Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., \\>75 years, Eastern Cooperative Oncology Group \\[ECOG\\] performance status ≥2, severe pulmonary disorder, total bilirubin \\>1.5X ULN; and\n  3. Platelet count ≥25,000\u002Fper microliter (μ); and\n  4. Absolute neutrophil count (ANC) ≥100 cells\u002FμL.\n* For participants only with hematologic malignancies other than AML or MDS, or with solid tumors:\n\n  1. Platelet count ≥100,000\u002FμL; and\n  2. ANC ≥1000 cells\u002FμL.\n* ECOG performance status of 0 to 3.\n* Hepatic function defined per the National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP) Organ Dysfunction Working Group (ODWG) as:\n\n  1. Normal hepatic function (Group A): total bilirubin ≤1× ULN; aspartate aminotransferase (AST): ≤1× ULN;\n  2. Moderate hepatic impairment (Group B): total bilirubin \\>1.5 to 3 × ULN; AST: any value;\n  3. Severe hepatic impairment (Group C): total bilirubin \\>3 × ULN; AST: any value.\n* Adequate renal function defined as creatinine clearance (CLcr, \\>50 mL\u002Fmin according to the Cockcroft-Gault equation):\n\nCLcr (mL\u002Fmin) = \\[(140-age(years)\\] × weight (in kg)\u002F 72 × serum creatinine (in mg\u002FdL)) × 0.85 \\[if female\\]\n\n* No major surgery within 30 days of first administration of oral decitabine and cedazuridine.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.\n* Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6months after completing treatment\n* Male participants with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) and must agree not to father a child while receiving treatment with oral decitabine and cedazuridine and for at least 3 months after completing treatment.\n\nExclusion Criteria:\n\n* Treatment with azacitidine or decitabine within 4 weeks before screening. Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.\n* Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection 30 days prior to first dose.\n* Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment, or ongoing clinically significant adverse events from previous treatment.\n* Concurrent MDS therapies, including lenalidomide, erythropoietin, cyclosporine\u002Ftacrolimus, granulocyte-colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. Prior treatment with these agents is permitted, provided that completion is at least 1 week before the first dose of study treatment. Short-term use of G-CSF for febrile neutropenia is permitted at the discretion of the treating physician and should be guided by accepted practice or institutional guidelines. Hematopoietic growth factors will not be routinely used unless cleared by Taiho medical expert.\n* Administration of live (attenuated) vaccines within 4 weeks before the first administration of oral decitabine and cedazuridine until after the follow-up visit. Other vaccines, e.g., inactivated or ribonucleic acid (RNA)-based, may be administered but should not occur from 7 days before first administration of oral decitabine and cedazuridine until after the follow-up visit.\n* High medical risk because of other conditions such as uncontrolled systemic diseases, active uncontrolled infections, or comorbidities that may put the participant at risk of not being able to complete 1 cycle of treatment.\n* Conditions which likely promote delayed ventricular repolarization (QT prolongation):\n\n  1. QTc using Fridericia's correction (QTcF) at screening or Day -1 \\>470 ms for males and \\>480 ms for females.\n\n     or\n  2. History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome).\n\n     or\n  3. Concomitant medications that prolong the QT\u002FQTc interval.\n* Cardiac abnormalities or unstable cardiovascular conditions:\n\n  1. Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV).\n\n     or\n  2. Uncontrolled treated\u002Funtreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥180 millimeters of mercury (mmHg) and\u002For diastolic blood pressure ≥110 mmHg; current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \\\u003C90 mmHg and\u002For diastolic blood pressure \\\u003C50 mmHg).\n* Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the participant to high risk of noncompliance with the protocol.\n* In participants with AML\u002FMDS, rapidly progressive or highly proliferative disease or other criteria that render the participant at high risk of requiring intensive cytotoxic chemotherapy within the next 3 months.\n* Life-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, that, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of oral decitabine and cedazuridine, or compromise completion of the study or integrity of the study outcomes.\n* Untreated central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks before screening.\n* Participants infected with human immunodeficiency virus (HIV).\n* Positive blood screen for hepatitis C antibody (HCV+) and positive RNA polymerase chain reaction (PCR). Participant can be included if HCV+ but negative for RNA PCR.\n* Positive blood screen for hepatitis B surface antigen (HBsAg+). Participants with positive blood screen for hepatitis B surface antibody (HBsAb+) and negative hepatitis B core antibody (HBcAb-) can be included if negative for hepatitis B surface antigen (HBsAg-).\n* Average intake of more than 24 units of alcohol per week for male participants and 17 units per week for female participant (1 unit of alcohol equals 10 mL of pure alcohol, i.e., approximately 250 mL of beer, 75 mL of wine, or 25 mL of spirits).\n* Donation or loss of more than 500 mL of blood within 60 days prior to the first study drug administration.\n* Hypersensitivity to decitabine, cedazuridine, or any of the excipients in oral decitabine and cedazuridine.",{"count":106,"type":21},27,[108],"PHASE1","This is a Phase 1b, multicenter, open-label, pharmacokinetic (PK), and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with moderate and severe hepatic impairment and cancer participants with normal hepatic function as control participants. Participants with severe hepatic impairment will be enrolled only after the safety evaluation of at least 6 participants with moderate hepatic impairment has been determined and supports the enrollment of participants with severe hepatic impairment. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration is per participant approximately up to 8 weeks.",[111,112],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","2026-05-27",{"date":115,"type":42},"2026-05-28",{"date":117,"type":42},"2022-12-23",{"date":79,"type":21},{"name":48,"class":49},22,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":137,"locationsCount":138},"100435720","phase-1-study-to-evaluate-the-pharmacokinetics-and-safety-of-oral-decitabine-and-cedazuridine-in-cancer-patients-with-renal-impairment-100435720","NCT04953897","Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment","A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Severe Renal Impairment and Cancer Patients With Normal Renal Function","Inclusion Criteria:\n\n* Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment cycle.\n* Participants must have a histologically or cytologically confirmed malignancy as follows:\n\n  1. A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available.\n\n     or\n  2. AML or MDS. or\n  3. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available.\n* For participants with AML\u002FMDS only:\n\n  1. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification or\n  2. Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., age \\>75 years, Eastern Cooperative Oncology Group \\[ECOG\\] performance ≥2, severe pulmonary disorder, total bilirubin 1.5 × upper limit of normal \\[ULN\\]); or\n  3. Platelet count ≥25,000\u002Fper microliter (μL); or\n  4. Absolute neutrophil count (ANC) ≥100 cells\u002FμL.\n* For participants with only hematologic malignancies other than AML or MDS, or solid tumors:\n\n  1. Platelet count ≥100,000\u002FμL; and\n  2. ANC ≥1000 cells\u002FμL.\n* ECOG performance status of 0 to 3.\n* Adequate hepatic function defined as:\n\n  1. Total or direct bilirubin ≤1.5X upper limit of normal (ULN); and\n  2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5X ULN.\n* Participants must have a body surface area (BSA)-adjusted CLcr using to the Cockcroft-Gault equation:\n\n  1. Participants without renal impairment (Group B): ≥80 mL\u002Fmin\u002F1.73m\\^²;\n  2. Participants with severe renal impairment (Group A): \\\u003C30 mL\u002Fmin\u002F1.73m\\^², not requiring dialysis;\n  3. CLcr must be stable with \\\u003C30% deviation allowed from screening to Day -1 (Baseline). Participants shifting outside the prospected renal function category (normal renal function or severe renal function) on Day-1 Baseline need to be agreed by Taiho medical expert whether they are allowed to remain in the original category that was assessed at screening.\n* No major surgery within 30 days of first administration of oral decitabine and cedazuridine.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.\n* Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6 months after completing treatment.\n* Male participants with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) and must agree not to father a child while receiving treatment with oral decitabine and cedazuridine for at least 3 months after completing treatment.\n\nExclusion Criteria:\n\n* Treatment with azacitidine or decitabine within 4 weeks before Screening. Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.\n* Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection 30 days prior to first dose.\n* Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment, or ongoing clinically significant adverse events from previous treatment.\n* Concurrent MDS therapies, including lenalidomide, cyclosporine\u002Ftacrolimus, granulocyte-colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. Prior treatment with these agents is permitted, provided that completion is at least 1 week before the first dose of study treatment. Short-term use of G-CSF for febrile neutropenia is permitted at the discretion of the treating physician and should be guided by accepted practice or institutional guidelines. Hematopoietic growth factors will not be routinely used unless cleared by Taiho medical expert.\n* Administration of live (attenuated) vaccines within 4 weeks before the first administration of oral decitabine and cedazuridine until after the follow-up visit. Other vaccines, e.g., inactivated or ribonucleic acid (RNA)-based, may be administered but should not occur from 7 days before first administration of oral decitabine and cedazuridine until after the follow-up visit.\n* High medical risk because of other conditions such as uncontrolled systemic diseases, active uncontrolled infections, or comorbidities that may put the participants at risk of not being able to complete 1 cycle of treatment.\n* Conditions which likely promote delayed ventricular repolarization (QT prolongation):\n\n  1. Corrected QT interval (QTc) using Fridericia's correction (QTcF) at Screening or Day -1 \\>470 milliseconds (ms) for males and \\>480 ms for females or\n  2. History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or\n  3. Concomitant medications that prolong the QT\u002FQTc interval\n* Cardiac abnormalities or unstable cardiovascular conditions:\n\n  1. Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV) or\n  2. Uncontrolled treated\u002Funtreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥ 180 millimeters of mercury (mmHg) and\u002For diastolic blood pressure ≥ 110 mmHg; current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \\\u003C90 mmHg and\u002For diastolic blood pressure \\\u003C50 mmHg).\n* Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the participants to high risk of noncompliance with the protocol.\n* In participants with AML\u002FMDS, rapidly progressive or highly proliferative disease or other criteria that render the participants at high risk of requiring intensive cytotoxic chemotherapy within the next 3 months.\n* Life-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, that in the investigator opinion, could compromise the participant safety, interfere with the absorption or metabolism of oral decitabine and cedazuridine, or compromise completion of the study or integrity of the study outcomes.\n* Untreated central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks before screening.\n* Participants infected with human immunodeficiency virus (HIV).\n* Participants with active hepatitis B or hepatitis C infection.\n* History of alcohol abuse or drug addiction (including soft drugs like cannabis products).\n* Average intake of more than 24 units of alcohol per week for male participants and 17 units per week for female participants (1 unit of alcohol equals 10 milliliters (mL) of pure alcohol, i.e., approximately 250 mL of beer, 75 mL of wine or 25 mL of spirits).\n* Donation or loss of more than 500 mL of blood within 60 days prior to the first study drug administration.\n* Hypersensitivity to decitabine, cedazuridine, or any of the excipients in oral decitabine and cedazuridine.",{"count":129,"type":21},18,[108],"This is a Phase 1b, multicenter, open-label, PK, and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with severe renal impairment and cancer participants with normal renal function as matched control participants. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration per participant is approximately up to 8 weeks.",[111,112],{"date":115,"type":42},{"date":135,"type":42},"2021-12-15",{"date":79,"type":21},{"name":48,"class":49},21,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100382183","phase-2-a-multi-phase-study-of-astx030-azacitidine-and-cedazuridine-in-myeloid-neoplasm-alone-or-in-combination-with-venetoclax-in-aml-aztound-study-100382183","NCT04256317","A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)","A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects With Myeloid Neoplasm or in Combination With Venetoclax in Subjects With AML (AZTOUND Study)","Inclusion Criteria:\n\n* Phase 2 Monotherapy:\n\n  1\\. Has Confirmed MDS, CMML, or other MDS\u002FMPN diagnosis who are candidates to receive and benefit from single agent azacitidine and as applicable according to local country approvals and\u002For local institution standard practice.\n* Phase 3 Monotherapy:\n\n  1. Has confirmed MDS or CMML and is a candidate to receive and benefit from single agent azacitidine as applicable according to local country approvals and\u002For local institution standard practice:\n\n     a) French-American-British myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and CMML or MDS with intermediate-2 or high risk MDS according to the International Prognostic Scoring System (IPSS).\n  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n  3. Participants with adequate organ function.\n  4. For participants with prior allogeneic stem cell transplant, no evidence of graft-versus-host disease (GVHD).\n  5. Participants with no major surgery within 3 weeks before first study treatment.\n  6. Participants with no cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before first study treatment.\n  7. Is able to swallow the number of tablets\u002Fcapsules required for the treatment assignment within a 10-minute period and tolerate 4 hours of fasting.\n  8. Participants with projected life expectancy of at least 12 weeks.\n* Phase 1 and Phase 2 Combination Therapy:\n\n  1. Has histological confirmation of newly diagnosed AML by World Health Organization (WHO) 2022 criteria (Phase 1) or 2016 criteria (Phase 2).\n  2. Participants with projected life expectancy of at least 12 weeks.\n  3. Must be considered ineligible for intensive induction chemotherapy defined by the following:\n\n     a. Aged 75 years or older, or b. Aged 18 to 74 years with at least one of the following comorbidities: i. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).\n\n     ii. Severe pulmonary disorder (e.g., diffusing capacity of the lung for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second \\[FEV1\\] ≤65%). iii. Creatinine clearance ≥30 mL\u002Fmin to \\\u003C45 mL\u002Fmin. iv. Moderate hepatic impairment with total bilirubin \\>1.5 to ≤3.0 × upper limit of normal (ULN).\n\n     v. ECOG Performance Status of 2 or 3.\n  4. Has an ECOG Performance Status of 0-2 for participants ≥75 years of age or 0-3 for participants 18 to 74 years of age.\n\nExclusion Criteria:\n\n* All Monotherapy Phases:\n\n  1. Has an active uncontrolled gastric or duodenal ulcer.\n  2. Has poor medical risk because of other conditions.\n  3. Has known human immunodeficiency virus (HIV) infection.\n  4. Is known to be positive for Hepatitis B or C infection.\n  5. Has a life-threatening illness.\n  6. Has a history of other malignancies prior to study entry, with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected or adequately treated and controlled with other modalities; and any early stage malignancy for which no definitive therapy is required.\n  7. Participants with MDS\u002FMPN including CMML who have clinical extramedullary disease including clinically palpable hepatomegaly or splenomegaly.\n  8. Has previous treatment with more than 1 cycle of decitabine, azacitidine, or guadecitabine (Phases 2 and 3 only).\n  9. Has been treated with any investigational drug or therapy within 2 weeks, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant adverse events from previous treatment with investigational drug or therapy.\n  10. Has a known or suspected hypersensitivity to cedazuridine or azacitidine or any of their excipients.\n  11. Cannot discontinue treatment with any drugs that delay gastric emptying such as glucagon-like peptide-1 (GLP-1) and\u002For gastric inhibitory polypeptide (GIP) agonists in Cycles 1 and 2 of the study.\n  12. Has a known or suspected hypersensitivity to cedazuridine or azacitidine or any of their excipients.\n* Phase 1 and Phase 2 Combination Therapy:\n\n  1. Has a history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.\n  2. Has the following karyotype abnormalities: t(15;17) or other acute promyelocytic leukemia variants that remain sensitive to all-trans retinoic acid (ATRA) therapy \\[t(8;21) and inv(16) are excluded in Phase 2 only\\].\n  3. Has known active central nervous system involvement from AML.\n  4. Has known human immunodeficiency virus (HIV) infection.\n  5. Is known to be positive for Hepatitis B or C infection.\n  6. Has severe hepatic impairment\n  7. Has severe renal impairment\n  8. Has a malabsorption syndrome or other condition that precludes enteral route of administration.\n  9. Has a cardiovascular disability status of New York Heart Association Class \\>2.\n  10. Has significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular, or pulmonary disease; or any other medical condition that in the opinion of the investigator would adversely affect his\u002Fher participation in this study.\n  11. Has clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal).\n  12. Has a history of other malignancies prior to study entry with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or adequately treated and controlled with other modalities); and any early stage malignancy for which no definitive therapy is required.\n  13. Has a WBC count \\>25,000\u002F microliters (μL) (hydroxyurea treatment is permitted to meet this criterion).\n  14. Has received treatment with any of the following:\n\n      1. A hypomethylating agent (azacitidine or decitabine) or venetoclax, including prior treatment for MDS.\n      2. Chimeric Antigen Receptor (CAR)-T cell therapy.\n      3. Investigational therapies for MDS or AML.\n  15. Cannot discontinue treatment with any of the following:\n\n      1. Prophylactic antifungal therapy with CYP3A inhibitor activity or other concomitant medications with moderate or strong CYP3A inhibitor activity ≥7 days or 5 halflives, whichever is greater, prior to Cycle 1 Day 1 (C1D1).\n      2. Drugs that are strong CYP3A or P-gp inhibitors ≥7 days or 5 half-lives, whichever is greater, prior to C1D1.\n  16. Cannot avoid concomitant drugs known as moderate or strong CYP3A inducers.\n  17. Cannot discontinue treatment with any drugs that delay gastric emptying such as GLP-1 and\u002For GIP agonists in Cycles 1 and 2 of the study.\n  18. Is participating in another research study requiring interventions such as drug therapy or study procedures.\n  19. Has a known or suspected hypersensitivity to cedazuridine, azacitidine, venetoclax, or any of their excipients.\n  20. Has known significant mental illness or other conditions such as alcohol or other substance abuse or addictions\n  21. Consumes grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit ≤7 days prior to C1D1.",{"count":147,"type":21},316,[24,149],"PHASE3","Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML.\n\nThe duration of this multi-phase study is approximately 8 years.",[112,111,152,153],"Myelodysplastic Syndrome\u002FNeoplasm","Chronic Myelomonocytic Leukemia",[155,156,157,158,159,160,161,162,163,164,165,166],"ASTX030","Myeloid Neoplasm","Hematologic Disease","Leukemia","Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome (MDS)","Chronic Myelomonocytic Leukemia (CMML)","Vidaza™","Azacitidine","Azacitidine and cedazuridine drug combination","Venetoclax","Venclexta™","2026-04-29",{"date":169,"type":42},"2026-04-30",{"date":171,"type":42},"2020-05-21",{"date":173,"type":21},"2028-11-01",{"name":48,"class":49},71,""]