EUCTR2007-000502-70-DE进行中（未招募）不适用
An open-label phase I/II (proof of concept) trial of an combination of Nilotinib (AMN 107) and RAD001 in patients with acute myeloid leukemia - CAMN107ADE01
Technical University of Munich0 个研究点开始时间: 2007年12月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •- Patients with:
- •De novo AML or secondary AML from MDS who are not candidates for
- •myelosuppressive chemotherapy, or
- •De novo AML or secondary AML from MDS who have relapsed disease or are
- •refractory to standard therapy
- •- Patients at least 18 years or older
- •- Patients with WHO performance status of 0
- •to 2 with a life expectancy under treatment of at least 3 months
- •- Patients must have recovered from prior cytotoxic chemotherapy; treatment with
- •Hydroxyurea or Ara-C is allowed until 24 hours to first administration of study drug.
- •- Patients must have a serum creatinine of and total bilirubin - Female patients of childbearing potential must have negative pregnancy test within
- •7 days before initiation of study drug dosing. Postmenopausal women must be
- •amenorrheic for at least 12 months to be considered of non-childbearing potential.
- •Male and female patients of reproductive potential must agree to employ an
- •effective barrier method of birth control throughout the study and for up to 6
- •months following discontinuation of study drug.
- •- Written informed consent obtained according to local guidelines.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with AML FAB M3.
- •- Patients with an expected doubling of the peripheral blast within one week.
- •- Patients who had prior allogeneic, syngeneic, or autologous bone marrow
- •transplant or stem cell transplant less than 2 months previously.
- •- Impaired cardiac function, including any one of the following:
- •LVEF < 45% or below the institutional lower limit of the normal range
- •(whichever is higher) as determined by MUGA scan or echocardiogram
- •Complete left bundle branch block
- •Use of a cardiac pacemaker
- •ST depression of > 1mm in 2 or more leads and/or T wave inversions in 2 or
- •more contiguous leads
- •Congenital long QT syndrome
- •History of or presence of significant ventricular or atrial tachyarrhythmias
- •Clinically significant resting bradycardia (< 50 beats per minute)
- •QTc > 450 msec on screening ECG (using the QTcF formula)
- •Right bundle branch block plus left anterior hemiblock, bifascicular block
- •Myocardial infarction within 12 months prior to starting otinib
- •Unstable angina diagnosed or treated during the past 12 months
- •Other clinically significant heart disease (e.g., congestive heart failure,
- •uncontrolled hypertension, history of labile hypertension, or history of poor
- •compliance with an antihypertensive regimen)
- •- Female patients who are pregnant or breast feeding, or adults of childbearing age
- •not employing an effective method of birth control.
- •- Concurrent severe and/or uncontrolled medical or psychiatric condition which may
- •interfere with the completion of the study.
- •- Patients who had more than 2 prior regimens for their current relapsed or current
- •primary refractory disease
- •- Patients with uncontrolled active infection.
- •- Patient with any pulmonary infiltrate on the baseline chest X-ray known to be new
- •in the previous 4 weeks. Prior treatment with any investigational drug within the
- •preceding 4 weeks
- •- Chronic treatment with systemic steroids or another immunosuppressive agent
- •- Uncontrolled brain or leptomeningeal metastases, including patients who continue
- •to require glucocorticoids for brain or leptomeningeal metastases
- •- Other malignancies within the past 3 years except for adequately treated
- •carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- •- Other concurrent severe and/or uncontrolled medical disease which could
- •compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled
- •hypertension, severe infection, severe malnutrition, unstable angina, or congestive
- •heart failure - New York Heart Association Class III or IV, ventricular arrhythmias
- •active ischemic heart disease, myocardial infarction within six months, chronic liver
- •or renal disease, active upper GI tract ulceration)
- •- A known history of HIV seropositivity
- •- Impairment of gastrointestinal function or gastrointestinal disease that may
- •significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled
- •nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- •- Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
- •(except low dose coumarin)
- •- Women who are pregnant or breast feeding, or women able to conceive and
- •unwilling to practice an effective method of birth control. (Women of childbearing
- 另有 2 项未显示
研究者
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