EUCTR2014-002217-31-DE进行中（未招募）1 期
A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 265
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Subject is =18 years of age at the time of obtaining informed consent.
- •2) Subject is defined as morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) and fulfills one of the followings:
- •Refractory to at least 1 cycle of induction chemotherapy
- •Relapsed after achieving remission with a prior therapy
- •3) Subject has an Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •4) Subject’s interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT).
- •5) Subject must meet the following criteria as indicated on the clinical laboratory tests.
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x institutional upper limit normal (ULN)
- •Total serum bilirubin =1.5 x institutional ULN
- •Serum creatinine =1.5 x institutional ULN or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •1. Subject was diagnosed as acute promyelocytic leukemia (APL).
- •2. Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
- •3. Subject has active malignant tumors other than AML or Myelodysplastic Syndrome (MDS).
- •4. Subject has persistent non-hematological toxicities of= Grade 2 (CTC AE v4), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).
- •5. Subject has had hematopoietic stem cell transplant (HSCT) and meets any of the following:
- •Is within 2 months of transplant from C1D1
- •Has clinically significant graft-versus-host disease requiring treatment
- •Has = Grade 2 persistent non-hematological toxicity related to the transplant
- •Donor lymphocytes infusion (DLI) is not permitted = 30 days prior to study registration or during the first cycle of treatment on the study in Cohort 1 and first two cycles of the treatment in Cohort 2.
- •6. Subject has clinically active central nervous system leukemia.
- •7. Subject has disseminated intravascular coagulation abnormality (DIC).
- •8. Subject has had major surgery within 4 weeks prior to the first study dose.
- •9. Subject has had radiation therapy within 4 weeks prior to the first study dose.
- •10. Subject has congestive heart failure NYHA class 3 or 4, or subject with a history of congestive
- •heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within
- •3 months prior to study entry results in a left ventricular ejection fraction that is = 45%.
- •11. Subject with mean Fridericia-corrected QT interval (QTcF) > 450 ms
- •at Screening based on central reading.
- •12. Subject with Long corrected QT interval (QTc) Syndrome at
- •13. Subject with hypokalemia and hypomagnesemia at Screening
- •(defined as values below lower limit of normal [LLN]).
- •14. Subject requires treatment with concomitant drugs that are strong
- •inhibitors or inducers of CYP3A4 or of P-glycoprotein (P-gp) or
- •substrates of multidrug and toxin extrusion 1 (MATE 1) with the
- •exception of antibiotics, antifungals, and antivirals that are used as
- •standard of care post-transplant or to prevent or treat infections and
- •other such drugs that are considered absolutely essential for the care of
- •the subject.
- •15. Subject requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR
- •receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely
- •essential for the care of the subject.
研究者
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