CTIS2022-500609-42-00招募中1 期
A Phase 2a/2b, Open-label, Proof of Concept (Phase 2a) and Double-blind, Randomized, Placebo-Controlled (Phase 2b), Multicenter, Efficacy, and Safety Study of AG-946in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes - AG946-C-002
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 117
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •For both Phase 2a and phase 2b: 1.At least 18 years of age at the time of providing informed consent 2.Documented diagnosis of MDS according to World Health Organization (WHO) classification, that meets IPSS-R classification (Appendix3) of lower-risk disease (risk score: =3.5) and <5% blasts as determined by the participant’s bone marrow biopsy/aspirate during the Screening Period 3. An Hb concentration <11.0 g/dL during the 4-week Screening Period 4.Eastern CooperativeOncology Group (ECOG) Performance Status score of 0, 1, or 2 5. If taking iron chelation therapy, the iron chelation therapy dose must have been stable and started =56 days before administration of the first dose of study drug 6.Women of childbearing potential (WOCBP), must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use highly effective method of contraception, from the time of providing informed consent, throughout the study, and for 28days after the last dose of study drug; if the highly effective method of contraception is hormonal contraception, then an acceptable barrier method must also be used (see Appendix1for the definition of WOCBP and acceptable contraception methods) . Men with partners who are WOCBP must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use a condom from the time of providing informed consent throughout the study and for 28 days after the last dose of study drug. 7.Written informed consent from the participant before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study, Phase 2a: 1.Nontransfused or with LTB, based on transfusion history from the participant’s medical record, according to revised IWG 2018 criteria (Appendix4):a.NTD: <3 RBC units in the 16-week period before administration of the first dose of study drug and no transfusions in the 8-week period before administration of the first dose of study drug, or b.LTB: 3 to 7 RBC units in the 16-week period before administration of the first dose of study drug and <4 RBC units in the 8-week period before administration of the first dose of study drug, Phase 2b: 1.Nontransfused, with LTB, or with HTB, based on transfusion history from the participant’s medical record, according to revised IWG 2018 criteria (Appendix4): a.NTD: <3 RBC units in the 16-week period before randomization and no transfusions in the 8-week period before randomization, or b.LTB: 3 to 7 RBC units in the 16-week period before randomization and <4 RBC units in the 8-week period before randomization, or HTB: =8 RBC units in the 16-week period before randomization and =4 RBC units in the 8-week period before randomization 2.Up to 2 prior therapies including erythropoiesis-stimulating agents (ESAs) (eg, erythropoietin [EPO], EPO + granulocyte colony-stimulating factor [G-CSF]) and/or luspatercept
排除标准
- •1.Known history of acute myeloid leukemia, 6.History of hepatobiliary disorders, as defined by: a. Serum AST >2.5 × ULN (unless due to hemolysis and/or hepatic iron deposition) and ALT >2.5 × ULN (unless due to hepatic iron deposition) b. Serum bilirubin >ULN, if the elevation is associated with clinically symptomatic choledocholithiasis, cholecystitis, biliary obstruction, or hepatocellular disease, 7. Renal dysfunction, as defined by an estimated glomerular filtration rate (eGFR) <45mL/min/1.73 m2, 8.Active infection requiring systemic antimicrobial therapy at the time of providing informed consent. If antimicrobial therapy is required during the Screening Period, screening procedures should not be performed while antimicrobial therapy is being administered, and the last dose of antimicrobial therapy must be administered =7 days before administration of the first dose of study drug (phase 2a) or =7 days before randomization (phase 2b)., 14.Platelet count =75,000/µL (75 × 109/L) – Phase 2a; Platelet count <50,000/µL (50 × 109/L) – Phase 2b during Screening; platelet transfusions within 28days before or during Screening, 9.Major surgery within 12 weeks before administration of the first dose of study drug. Participants must have completely recovered from any previous surgery before administration of the first dose of study drug (phase 2a) or randomization (phase 2b)., 11.Positive test for hepatitis C virus antibodywith evidence of active HCV infection, or positive test for hepatitis B surface antigen (HBsAg, 12.Positive test for HIV-1 Ab or HIV-2 Ab, 17.Current enrolment or past participation (within 4 weeks or a time frame equivalent to 5half-lives of the investigational study drug before administration of the first dose of study drug or, whichever is longer) in any other clinical study involving an investigational treatment or device, 18.Known allergy to AG-946 or its excipients, 19.Pregnant or breastfeeding, 13.Absolute neutrophil count <500/µL (0.5 × 109/L), 20.Any medical, hematologic, psychological, or behavioural condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data, 10.For any malignancy, except MDS: History of malignancy (active or treated) =5 years before providing informed consent, except for no melanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ., 2.Secondary MDS, defined as MDS that is known to have arisen as a result of chemical injury or treatment with chemotherapy and/or radiation for other diseases, 3Prior exposure to a pyruvate kinase activator, and/or disease-modifying agents for underlying MDS: • Immunomodulatory drugs (IMiDs) such as lenalidomide at the Investigator’s discretion and in consultation with the Medical Monitor, participants who received =1 week of treatment with IMiDs may not be excluded, provided their last dose was =8 weeks before administration of the first dose of study drug. • Hypomethylating agents (HMAs); at the Investigator’s discretion and in consultation with the Medical Monitor, participants who received =2 doses of HMAs may not be excluded, provided that their last dose was =8 weeks before administration of the first dose of study drug • Isocitrate dehydrogenase (IDH) inhibitors • Immunosuppressive therapy (IST) • Allogeneic or autologous stem cell transplant 4.Currently receiving treatment with G
研究者
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