JPRN-jRCT2080222660已完成1 期
Phase 1 study of SGI-110 in patients with acute myeloid leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
研究概览
简要总结
SGI-110 SC injection was generally well tolerated at 36, 60, and 90 mg/m2 (5-day) and 60 mg/m2 (10-day) in Japanese subjects with AML. No significant safety concerns were identified in this trial.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Male or female patients with a diagnosis of AML (WHO classification 2008).
- •- Patients, 20 years of age or older, who are unresponsive to standard chemotherapy or have relapsed following standard chemotherapy
- •- Patients, 65 years of age or older, who are not eligible for standard intensive chemotherapy
- •2) Patients with ECOG performance status (PS) of 0 to 2.
- •3) Patients with adequate organ function.
- •4) Women of child-bearing potential must not be pregnant or breast feeding (pregnancy test will be performed at Screening). Women of child bearing potential and all men with female partners of child bearing potential must practice two medically acceptable methods of birth control and must not become pregnant or father a child while receiving treatment with SGI-110 and for 3 months following last dosing.
- •5) Patients who have undergone prior allogeneic hematopoietic stem cell transplantation must have no evidence of active graft-versus host disease (GVHD) and must be off immunosuppressive therapy by 2weeks or longer prior to IMP administration.
排除标准
- •1) Patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or (PML/RARA) karyotype abnormalities (include other variant types of APL).
- •2) Patients with multiple cancers (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 3 years).
- •3) Subjects with life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk.
- •4) Patients with poorly controlled arrhythmias, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
- •5) Patients with symptomatic central nervous system involvement.
研究者
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