EUCTR2011-005408-13-GB进行中（未招募）1 期
A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) - Not applicable
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
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 has provided an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved signed Informed Consent and privacy disclosure as per national regulations (e.g., HIPAA Authorization for U.S. sites) prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •2. Subject is male or female = 18 years of age.
- •3. Subject has morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS) as defined by the World Health Organization (WHO) criteria, as determined by pathology review at the treating institution and has relapsed or is refractory after 1 second line (salvage) regimen or after HSCT (Appendix 8).
- •4. Subject is positive for FLT3-ITD activating mutation in bone marrow or peripheral blood (>10% allelic ratio as determined by central lab).
- •5. ECOG performance status of 0 to 2 (Table 4).
- •6. In the absence of rapidly progressing disease clearly documented by the investigator, the interval from prior treatment to time of AC220 administration will be at least 2 weeks (14 days) for prior cytotoxic agents or at least 5 half-lives for prior noncytotoxic agents, including immunosuppressive therapy post HSCT.
- •7. Persistent chronic clinically significant nonhematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade = 1.
- •8. Patients - both males and females - with reproductive potential are eligible if the following criteria is met:
- •? female subject is:
- •- post-menopausal (defined as at least 2 years without menses) prior to Screening visit; or
- •- surgically sterile (at leats 1 month) prior to Srceening visit; or
- •- childbearing potential without contraception
- •? female subject of childbearing potential has negative pregnancy test at Screening visit and agrees to use contraception consisting of two forms of birth control (one of which must be a barrier method) throughout the study period
- •? male subject with partner(s) of childbearing potential must agree to use contraception consisting of two forms of birth control (one of which must be a barrier method) and agrees to no sperm donation throughout the study period
- •9. Subject must have adequate renal, hepatic, and coagulation parameters as indicated by the following laboratory values:
- •? Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) = 2.5 x institutional upper limit of normal (ULN)
- •? Total bilirubin = 1.5 x institutional ULN
- •? Serum creatinine = 1.5 x institutional ULN and glomerular filtration rate (GFR) > 30mL/min (calculated by Cockcroft and Gault formula, Appendix 9).
- •10. Subject is able to comply with study procedures and follow-up examinations.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Subject received previous treatment with AC220.
- •2. Subject has a diagnosis of acute promyelocytic leukemia.
- •3. Subject has a diagnosis of chronic myelogenous leukemia (CML) in blast crisis.
- •4. Subject has AML or antecedent MDS secondary to prior chemotherapy.
- •5. Subject has had HSCT and has either of the following:
- •? Is within 100 days of transplant
- •? Is still taking immunosuppressive drugs
- •? Has clinically significant graft-versus-host disease requiring treatment
- •? Has Grade > 1 persistent nonhematological toxicity related to the transplant.
- •Donor lymphocyte infusion (DLI) is not permitted during the study or < 30 days prior to study entry.
- •6. Subject has clinically active CNS leukemia. If CNS leukemia is controlled and subject is receiving intrathecal (IT) therapy at study entry, subjects may be considered eligible at the discretion of the Investigator and with agreement of the Sponsor. Subjects should continue to receive IT therapy as clinically indicated.
- •7. Subject has received concurrent chemotherapy, immunotherapy, or radiotherapy within 14 days prior to the first dose of AC220, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation) within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
- •8. Subject requires treatment with concomitant drugs that prolong QT/QTc interval or with strong inhibitors or inducers of cytochrome P450-isozyme3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care posttransplant or to prevent or treat infections and other such drugs that are considered
- •absolutely essential for the care of the subject. (See Appendix 1)
- •9. Subject requires treatment with anticoagulant therapy.
- •10. Subject has a known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen.
- •11. Subject had major surgery within 4 weeks prior to first dose of AC220.
- •12. Subject has uncontrolled or significant cardiovascular disease,
- •? A myocardial infarction within 12 months prior to the start of study drug;
- •? Uncontrolled angina within 6 months prior to the start of study drug;
- •? History of congestive heart failure (CHF) New York Heart Association (NYHA) class 3 or 4, if a screening echocardiogram (ECHO) or Multiple Gate Acquisition Scan (MUGA) is performed either within 1 month prior to or during study screening and the result is a left ventricular ejection fraction (LVEF) that is = 45% (or institutional lower limit of normal value); then this is not exclusionary
- •? Heart rate < 50 beats per minute at Screening ECG;
- •? Diagnosed or suspected congenital long QT syndrome;
- •? Known family history of congenital long QT syndrome;
- •? QTc interval calculated by Fridericia's correction factor (QTcF) at
- •Screening and Day 1 (before AC220 dose) = 450 ms. The QTcF will be derived from the average QTcF in triplicate;
- •? Any history of second or third degre
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