[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shijiazhuang Yiling Pharmaceutical Co. Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100605407","phase-1-a-study-to-evaluate-the-effect-of-xy0206-on-the-qtc-interval-in-chinese-healthy-participants-100605407",false,"NCT07162116","A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants","A Single-center, Randomized, Double-blind, Placebo- and Positive Drug (Open-label Design) Controlled Phase I Clinical Study to Evaluate the Effect of a Single Oral Dose of XY0206 Tablets on QTc Interval in Healthy Chinese Participants.","XY0206-CQT","Inclusion Criteria:\n\n1. Participants voluntarily sign a written informed consent form.\n2. Male or female; aged between 18 and 45 years old (inclusive).\n3. Male participants weigh ≥ 50kg, female participants weigh ≥ 45kg, and their body mass index (BMI) is between 19.0 and 26.0 kg\u002Fm², inclusive.\n4. Physical examination, laboratory tests, and all trial-related examinations (vital signs, electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, etc.) at the screening stage are normal or have only minor abnormalities without clinical significance, and are deemed qualified by the clinical research doctor.\n5. Participants can communicate well with the researchers and comply with the protocol requirements to complete the study.\n\nExclusion Criteria:\n\nMedical history, past medical history, recent medication history:\n\n1. Those with a history of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory systems, etc.), mental disorders, or drug dependence;\n2. Those with a history of drug or food allergies, or specific allergies (such as asthma, urticaria, eczema, etc.); or those allergic to XY0206 tablets, moxifloxacin hydrochloride, or other fluoroquinolones, or the excipients contained therein; or those known to be allergic to FLT3 inhibitors;\n3. Those with a history of difficulty swallowing or any gastrointestinal diseases (or gastrointestinal resection, etc.) that affect drug absorption;\n4. Those with hemorrhoids or perianal diseases with regular\u002Fongoing bleeding, irritable bowel syndrome, inflammatory bowel disease; or those with habitual constipation or diarrhea;\n5. Those with a history of pancreatitis;\n6. Those who have undergone major surgery within 6 months before screening or whose surgical incisions have not fully healed; major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia, or incisional biopsies or significant traumatic injuries;\n7. Those who have donated blood within 3 months before screening, or plan to donate blood during this study, or have received blood transfusions or lost ≥200ml of blood within 4 weeks before screening;\n8. Those who have participated in 4 or more clinical trials within the past year; or those who have participated in any clinical trials and received investigational drugs or devices within 3 months before this trial;\n9. Those with a history of drug abuse within the past 5 years or have used drugs within 3 months before the trial;\n10. Those who have taken any prescription drugs, over-the-counter drugs, vitamin products, health supplements, or herbal medicines within 4 weeks before screening or within 5 half-lives (if known), whichever is longer; or those who have taken any drugs known to cause QT\u002FQTc interval prolongation or have a risk of causing torsades de pointes (TdP) within 4 weeks before screening;\n11. Those with a history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia;\n12. Those who have received vaccinations within 3 months before screening or plan to receive vaccinations during this study;\n13. Those with a history of fainting at the sight of blood or needles and cannot tolerate venous catheterization;\n\n    Health status:\n14. Those with neurological, mental, respiratory, cardiovascular, digestive, hematological and lymphatic, endocrine, musculoskeletal, urinary, or any other diseases or physiological conditions that may affect the study results at the time of screening;\n15. Those with a history of cardiovascular diseases or risk factors for torsades de pointes (TdP) at the time of screening, including but not limited to: unexplained syncope; heart failure; myocardial infarction; angina pectoris; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; long QT syndrome (LQTS) personal or family history; or a family history of sudden death;\n16. Those with 12-lead electrocardiogram results exceeding the standard at the screening or baseline period: PR \\> 200ms, QRS \\> 110ms, HR \\\u003C 50 bpm, QTcF \\> 450 ms (for both males and females); or those with abnormal electrocardiograms and the investigator deems the abnormalities clinically significant (such as atrioventricular block, potential bundle branch block, torsades de pointes (TdP), other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, clinically significant T-wave changes, or any 12-lead electrocardiogram results that may affect the QTc interval);\n17. Those with laboratory test results meeting the following abnormal ranges at the screening or baseline period:\n\n    a. Abnormal hematological indicators: i. White blood cells \\\u003C lower limit of normal (LLN); ii. Absolute neutrophil count \\\u003C LLN; iii. Platelet count \\\u003C LLN; iv. Hemoglobin \\\u003C LLN. b. Abnormal liver function: AST and\u002For ALT \\> upper limit of normal (ULN), total bilirubin and\u002For direct bilirubin \\> ULN; c. Creatinine \\> ULN, creatine kinase \\> ULN, creatine kinase isoenzyme \\> ULN, lipase \\> ULN, amylase \\> ULN; d. Metabolic abnormalities: serum triglycerides \\> 1.2 times ULN.\n18. Participants with positive hepatitis B surface antigen and\u002For hepatitis B e antigen, positive hepatitis C antibody, positive human immunodeficiency virus antibody, or positive Treponema pallidum antibody during the screening period;\n19. Participants with positive breath alcohol test or positive urine drug abuse screening at baseline;\n\n    Lifestyle restrictions:\n20. Participants with special dietary requirements who cannot adhere to the diet and corresponding regulations provided by the clinical research institution;\n21. Participants who cannot control special diets (including pitaya, mango, grapefruit and\u002For xanthine diet, caffeine-containing foods or beverages, strong tea, etc.) during the trial;\n22. Participants who have consumed special diets (including pitaya, mango, grapefruit and\u002For xanthine diet, caffeine-containing foods or beverages, strong tea, etc.) or engaged in vigorous exercise within 48 hours before administration, or have other factors that may affect drug absorption, distribution, metabolism, and excretion;\n23. Participants who have consumed alcohol frequently in the 6 months prior to administration, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or cannot stop alcohol intake during the trial;\n24. Participants who smoke more than 5 cigarettes per day in the 3 months prior to administration, or will use any tobacco products during the trial;\n\n    Contraception:\n25. Pregnant or lactating women or those with positive pregnancy tests;\n26. Participants who have used oral contraceptives within 30 days before screening (applicable to females only);\n27. Participants who have used long-acting estrogen or progesterone injections or implants within 6 months before screening (applicable to females only);\n28. Females of childbearing age who have had unprotected sexual intercourse with their partners within 14 days before screening;\n29. Participants of childbearing age, male or female, who have a plan to conceive from the time of signing the informed consent form until one year after the end of the trial, or who do not agree to use effective contraceptive methods, or do not agree to avoid freezing or donating sperm\u002Feggs.\n\n    Other criteria:\n30. Participants who are considered to have poor compliance or have any other factors that make them unsuitable for this trial by the investigator;\n31. The investigator, their family members, and related personnel of the research center;\n32. Students and subordinates of the investigator, employees of the sponsor, and other vulnerable participants;\n33. Participants who may be unable to complete the study for other reasons.",true,"ALL","18 Years","45 Years",{"count":22,"type":23},45,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This study plans to enroll 45 (Groups A, B, and C) to 75 healthy participants (including the sample size of other potential dose groups). The participants will be divided into three dose groups: 37.5 mg, 75 mg, and 150 mg. After taking the corresponding investigational product, participants are required to complete test procedures including QTc interval measurement , blood sampling, and vital sign monitoring. The entire test process lasts for 3 days. On the third day, after participants complete laboratory tests and are assessed by physicians as meeting the discharge criteria, they can be discharged.",[29],"Acute Myeloid Leukemia With FLT3\u002FITD Mutation","RECRUITING","2025-09-07",{"date":33,"type":34},"2025-09-09","ACTUAL",{"date":36,"type":34},"2025-07-06",{"date":38,"type":23},"2026-05",{"name":40,"class":41},"Shijiazhuang Yiling Pharmaceutical Co. Ltd","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100506626","phase-3-a-study-of-xy0206-versus-salvage-chemotherapy-in-patients-with-relapsed-or-refractory-aml-with-flt3-itd-mutation-alive-100506626","NCT05876832","A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)","Phase 3 Open-label, Multicenter, Randomized Study of XY0206 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3(FLT3)-Internal Tandem Duplication（ITD） Mutation","Inclusion Criteria:\n\n1. Age≥18 years old.\n2. Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization (WHO) classification as determined by pathology review at the treating institution.\n3. Subject is refractory to or relapsed after prior AML therapy (with or without hematopoietic stem cell transplant ):\n\n   * Advanced relapse after first-line AML therapy is defined as: the patients achieved Complete remission without minor residual diseases\u002Fcomplete remission\u002Fcomplete remission with partial hematologic recovery\u002Fcomplete remission with incomplete hematologic recovery\u002Fcomplete remission with incomplete platelet recovery\u002FMorphologic leukemia- free state(CRMRD-\u002FCR\u002FCRh\u002FCRi\u002FCRp\u002FMLFS )after first-line treatment and relapsed after 12 months with hematological relapse;\n   * Patients with relapsed \u002F refractory AML.\n   * Refractory to first-line AML therapy is defined as:the patient did not achieve CRMRD-\u002FCR\u002FCRh\u002FCRi\u002FCRp\u002FMLFS under initial therapy.A subject eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject.\n   * Early relapse:Relapse within 12 months after consolidation therapy after achieving CRMRD-\u002FCR\u002FCRh\u002FCRi\u002FCRp\u002FMLFS.\n   * Relapse after 12 months but nonresponse to conventional chemotherapy after achieving CRMRD-\u002FCR\u002FCRh\u002FCRi\u002FCRp\u002FMLFS.\n   * Second or more relapse.\n   * Patients who cannot tolerate intensive chemotherapy develop disease progression during continuous treatment with low-intensity drugs.\n   * Persistence of extramedullary leukemia.\n4. Patient is positive for FLT3-ITD mutation in bone marrow or whole blood.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n6. Expected survival ≥12 weeks .\n7. Patient must meet the following criteria as indicated on the clinical laboratory tests:\n\n   * Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of ≥50 mL\u002Fmin .\n   * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)\n   * Serum total bilirubin (TBL) ≤ 1.5 x ULN.\n   * Fridericia's Heart Rate Correction Formula (QTcF) interval ≤480 msec.\n8. Female patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first study drug administration.Female patients of childbearing potential and male must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug.\n9. The subject should be willing to provide evidence of valid diagnosis before treatment or undergo bone marrow puncture or biopsy for diagnosis, and receive bone marrow puncture or biopsy for efficacy evaluation after treatment.\n10. Patients volunteered to participate in this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patient was diagnosed as acute promyelocytic leukemia (APL), or Philadelphia chromosome（BCR-ABL）-positive leukemia (chronic myelogenous leukemia in blast crisis).\n2. Patients who received live vaccine (including live attenuated vaccine) within 4 weeks before randomization and\u002For planed to receive live vaccine after enrollment.\n3. Presence of FLT3-tyrosine kinase domain(TKD) mutation.\n4. Patients were prior failed adequate treatment with FLT3 inhibitors.\n5. AML with Central Nervous System Leukemia.\n6. Patient has AML secondary to prior chemotherapy for other neoplasms, except for MDS.\n7. Patients with other malignant tumors past or present,unless whose Disease-free survival period≥5 years.Non-melanin skin cancer, carcinoma in situ, or cervical intraepithelial neoplastic lesions with completed radical treatment (regardless of disease-free survival),and subjects with prostate cancer confined to the prostate and with no evidence of disease recurrence or progression,if they have started hormonal therapy or have undergone surgery to remove the malignancy or have undergone radical radiotherapy,will be eligible for the study.\n8. Pretrial treatment conditions:\n\n   * Patients who received hematopoietic stem cell transplantation within the 2 months before enrollment,or having clinically significant graft-versus-host disease (GVHD) or receiving systemic cortisol hormone therapy for GVHD.\n   * Patients who received chemotherapy, biological therapy, targeted anti-tumor therapy within 14 days before the first use of the drug in this study or within 5 half-lives of the drug, or radiation therapy within 28 days.\n   * Patients who participated in other clinical trials and received trial drugs within 28 days to the first study dose.\n   * Patients who have had major surgery or significant traumatic injury within 28 days to the first study dose or planted to require major surgery during study treatment.\n9. Concurrent disease conditions:\n\n   * Patients are hepatitis B surface antigen or core antibody actives positive,and hepatitis B virus(HBV) DNA ≥2000IU\u002FmL or 1×104 copy\u002FmL.\n   * Patients are hepatitis C virus (HCV) antibody actives positive and HCV-RNA quantification is above the upper limit of normal at each center.\n   * Human immunodeficiency virus (HIV) seropositivity.\n   * Patient has clinically obvious gastrointestinal abnormalities that may affect the intake, transport, or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc),patients with total gastrectomy or major gastrectomy (Billroth II), patients with a clear gastrointestinal bleeding tendency,or major gastrointestinal bleeding considered possible by the investigator.\n   * Patient has uncontrolled epilepsy history.\n   * Patient has uncontrolled hypertension defined as systolic blood pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg, despite optimal medical management and optimal measurement.\n   * Patient has clinically significant abnormal serum lipase or amylase indicators during screening.\n   * Patient has refractory intractable hypokalemia or hypomagnesemia.\n   * Patient has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation (DIC), hemophilia.\n   * Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month before study entry results in a left ventricular ejection fraction that is ≥ 45%.\n   * Patients with second degree (Mobitz II) or third degree atrioventricular block disease (except for patients who use the pacemaker) or complete left bundle branch block.\n   * Patients with new clinically significant arrhythmias (except for sinus tachycardia caused by anemia, infection and AML) or patients with previous arrhythmias that require long-term use of drugs with QT-prolonging effects.\n   * Patients with any one of the following diseases within 6 months prior to randomization:myocardial infarction,unstable angina pectoris,Patients undergoing coronary artery bypass graft(CABG) or peripheral artery bypass implantation,congestive heart-failure,Cerebrovascular events (including cerebral hemorrhage and cerebral infarction, etc.),Deep venous thrombosis (except for deep venous thrombosis due to peripherally inserted central venous catheter (PICC) catheterization),pulmonary embolism and other diseases that the researcher considers inappropriate to participate in this study.\n   * Patients with diagnosed or suspected long QT syndrome at screening (including a family history of long QT syndrome).\n   * Patient has an active uncontrolled infection.\n   * Patient has severe unhealed wounds, ulcers, or fractures.\n   * Females who are pregnant or breastfeeding.\n   * Patients are not suitable for the study in the investigator's opinion.",{"count":51,"type":23},312,[53],"PHASE3","The purpose of this study is to determine the clinical benefit of XY0206 therapy in participants with FLT3-ITD mutated AML who are refractory to or have relapsed after prior AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study is also to investigate the efficacy of XY0206 as assessed by CR\u002FCRh rate in these subjects。",[29],"NOT_YET_RECRUITING","2023-05-24",{"date":59,"type":34},"2023-05-26",{"date":61,"type":23},"2023-06-15",{"date":63,"type":23},"2027-07-01",{"name":40,"class":41},""]