[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chemotherapy-induced-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chemotherapy-induced-anemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100521856","phase-2-a-study-of-and017-in-cancer-related-anemic-patients-receiving-chemotherapy-100521856",false,"NCT06075030","A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy","A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Cancer-Related Anemia Patients Receiving Chemotherapy","Inclusion Criteria:\n\n1. Non-myeloid malignancy diagnosed by cytology\u002Fhistology\n2. Receiving and have received at least one cycle of drug therapy with a high myelosuppressive adverse effect, including but not limited to chemotherapeutic agents such as platinum, targeted agents, antibody-coupled drugs, immunosuppressive agents, etc., and are expected to continue such therapy within 8 weeks of enrollment\n3. ECOG score of 0-2 and an expected survival of 6 months or more.\n4. Mean hemoglobin \\\u003C10.0 g\u002FdL at screening test and one follow-up test (at least one week thereafter during the screening period), with a difference between the two tests of ≤1.0 g\u002FdL\n5. Total bilirubin \\\u003C1.5 x upper limit of normal (ULN) If Gilbert's syndrome (unconjugated hyperbilirubinemia) have a total bilirubin \\\u003C 3 x ULN.\n6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 x ULN.\n7. No iron deficiency, TSAT ≥ 20% and ferritin ≥ 100 ng\u002FmL at screening.\n8. Serum folate and vitamin B12 ≥ lower limit of normal at screening.\n9. eGFR \\>60 mL\u002Fmin\u002F1.73 at screening.\n\nExclusion Criteria:\n\n1. Hematocrit (Hct) ≥ 36 vol% at the screening assessment.\n2. Prior history of leukemia.\n3. Extensive bone metastases from breast cancer, head and neck cancer with combined whole blood (trilineage) cytopenia, bone marrow invasion from lymphoma, definite brain metastases (except for those whose symptoms have been controlled for ≥4 weeks) or bone marrow metastases.\n4. Combination of hereditary anemia, iron-granulocytic anemia, acute blood loss, active bleeding (three consecutive positive fecal occult bloods or clinical judgment of the investigator), hemolysis and other diseases that can cause anemia such as iron, folic acid or vitamin B12 deficiency.\n5. Active infection or inflammatory disease requiring systemic anti-infective therapy within 1 week prior to the first dose, including concurrent autoimmune diseases with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)\n6. Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.)\n7. Difficulty to take oral medications, or conditions that may have an impact on the absorption of gastrointestinal medications such as a history of gastrectomy\u002Fbowel resection or concomitant gastroparesis (excluding gastric polyps or colonic polypectomy).\n8. clinically significant bleeding (including the need for blood transfusion or a decrease in hemoglobin ≥ 2 g\u002FdL) within 4 weeks prior to the first dose, or a bleeding constitutional or bleeding risk that has not been medically or surgically corrected.\n9. Uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values \\> 90 mmHg and\u002For systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing)\n10. Concurrent congestive heart failure (New York Heart Association \\[NYHA\\] class III or higher).\n11. Clinically significant ECG abnormalities at the time of screening evaluation\n12. Medical history of significant liver disease or active liver disease\n13. History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or pulmonary infarction within 24 weeks prior to the screening evaluation\n14. History of prior thrombosis, significant coagulation abnormalities, history of hematologic disease, or history of ineffective erythropoietin therapy\n15. History of epilepsy or any past seizures.\n16. Positive hepatitis B surface antigen (HBsAg), or positive anti-hepatitis C virus (HCV) antibodies, or positive human immunodeficiency virus HIV at screening evaluation.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to determine the safety and efficacy of AND017 after 6 weeks of treatment in patients with cancer-related anemia who are receiving chemotherapy.",[26],"Chemotherapy Induced Anemia","NOT_YET_RECRUITING","2026-02-25",{"date":30,"type":31},"2026-02-27","ACTUAL",{"date":33,"type":20},"2027-12",{"date":35,"type":20},"2028-05",{"name":37,"class":38},"Kind Pharmaceuticals LLC","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100581743","phase-2-study-of-sss06-for-chemotherapy-induced-anemia-in-non-myeloid-malignancies-100581743","NCT06854276","Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies","A Randomized, Open-Label, Active-Controlled, Multicenter Phase II\u002FIII Clinical Study to Evaluate the Safety and Efficacy of SSS06 in the Treatment of Chemotherapy-Induced Anemia in Patients with Non-Myeloid Malignancies","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years at the time of signing the informed consent.\n* Histologically or cytologically confirmed diagnosis of non-myeloid malignancies.\n* Chemotherapy-induced anemia defined as hemoglobin (Hb) ≤100 g\u002FL at screening, with a documented decrease in Hb of ≥10 g\u002FL post chemotherapy initiation, as judged by the investigator.\n* Serum ferritin ≥50 ng\u002FmL and transferrin saturation (TSAT) ≥10% at screening.\n* Body weight ≥40 kg at screening.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or 2 at screening.\n* Expected survival ≥6 months.\n* Planned to receive at least 8 weeks of myelosuppressive chemotherapy starting from Day 1 of the study.\n* Childbearing women must agree to use reliable contraception and have no plans to conceive or donate eggs from the start of study drug administration until 6 months post-last dose. Men must agree to use reliable contraception and have no plans to father a child or donate sperm from the start of study drug administration until 6 months post-last dose.\n* Voluntarily sign informed consent, willing to participate in the trial, and able to comply with the protocol requirements for administration and follow-up, including examinations, visits, and other procedures.\n\nExclusion Criteria:\n\n* Patients undergoing myelosuppressive chemotherapy with an expected curative outcome.\n* Subjects receiving only hormone therapy, biologics, immunosuppressants (e.g., PD-1 and PD-L1 immune checkpoint inhibitors), or targeted therapies, or radiation therapy to treat\u002Fcontrol their tumors; however, subjects receiving chemotherapy in combination with these therapies may be included.\n* Subjects with a hematocrit (HCT) ≥ 36%.\n* Subjects who have undergone interventions (e.g., blood transfusion, erythropoiesis-stimulating agents (ESAs), or hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)) to elevate hemoglobin (Hb) levels to meet chemotherapy safety standards prior to the initiation of the scheduled chemotherapy regimen.\n* Subjects who received red blood cell (RBC) transfusions, ESAs, or HIF-PHIs within 4 weeks prior to enrollment.\n* Subjects with abnormal liver or kidney function test results: alanine aminotransferase (ALT) \\> 3×ULN, aspartate aminotransferase (AST) \\> 3×ULN, or total bilirubin (TBL) \\> 1.5×ULN (subjects with TBL up to 2×ULN may be included if ALT\u002FAST are within normal limits and the investigator deems no safety concerns). Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m² (calculated using the CKD-EPI formula).\n* Subjects with active systemic infections requiring treatment.\n* Subjects with a history of clinically significant cardiovascular disease, including New York Heart Association (NYHA) Class III or IV heart failure within the past 6 months, uncontrolled hypertension or hypotension, or severe valvular or endocardial disease history that may increase the risk of thromboembolic events.\n* Subjects who experienced thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack) within the past 6 months.\n* Subjects with clinically significant anemia due to other causes, such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, or genetic anemias (e.g., sickle cell anemia or thalassemia).\n* Subjects with clinically significant or uncontrolled chronic inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, Crohn's disease, celiac disease).\n* Subjects with severe or active liver disease.\n* Subjects planning to undergo major surgery during the treatment period (surgery with minimal blood loss that does not affect Hb concentration is exempt).\n* Subjects with myeloid malignancies.\n* Subjects with primary or metastatic malignant tumors in the central nervous system.\n* Subjects testing positive for human immunodeficiency virus (HIV) antibodies or syphilis antibodies.\n* Subjects positive for hepatitis B virus (HBV) or hepatitis C virus (HCV):\n\n  1. Subjects with inactive HBsAg carriers or stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL) may be included, with regular monitoring of HBV DNA during the study as recommended by the investigator.\n  2. Subjects with HCV antibody positivity (HCV-Ab+) may be included if HCV RNA is negative, with regular monitoring of HCV RNA during the study as recommended by the investigator.\n* Subjects who have used any investigational drugs within 4 weeks prior to Day 1 of treatment or plan to use such drugs during the clinical trial.\n* Subjects with a history of alcoholism, drug abuse, or addiction.\n* Subjects deemed unsuitable for participation in the study by the investigator.",{"count":47,"type":20},80,[23],"This study employs a multicenter, randomized, open-label, positive drug-controlled, multiple ascending dose clinical trial design to comprehensively evaluate the safety, tolerability, immunogenicity, and pharmacokinetic characteristics of SSS06 injection in patients with chemotherapy-induced anemia from non-myeloid malignancies, while also exploring its potential efficacy.",[51,52],"Chemotherapy-induced Anemia","Non-myeloid Malignancies","2025-02-25",{"date":55,"type":31},"2025-03-03",{"date":57,"type":20},"2025-03-01",{"date":59,"type":20},"2027-12-01",{"name":61,"class":38},"Shenyang Sunshine Pharmaceutical Co., LTD."]