EUCTR2012-004104-35-IT进行中（未招募）1 期
A phase IB/II, multicenter, open label, study of LEE011 in combination with MEK162 in adult patients with NRAS mutant melanoma
OVARTIS FARMA S.p.A.0 个研究点目标入组 58 人开始时间: 2013年8月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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 must have an Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0 - 2
- •- Patients enrolled into phase Ib may be enrolled
- •with evaluable disease only. Patients enrolled into the phase II
- •expansion must have at least one measurable lesion as defined by
- •RECIST 1.1 criteria.
- •- Patients must have adequate organ function, as defined by the
- •following parameters:
- •a. Bone marrow:
- •Absolute Neutrophil Count (ANC) = 1.5 x 109/L
- •Hemoglobin (Hgb) = 9 g/dL
- •Platelets = 75 x 109/L without transfusions within 21 days before 1st
- •b. Serum creatinine =1.5 ULN
- •c. Serum total bilirubin = 1.5 x upper limit of normal (ULN)
- •d. Aspartate Aminotransferase (AST) (serum glutamic oxaloacetic
- •transaminase [SGOT]) and ALT (SGPT) = 3 x ULN, except in patients
- •with tumor involvement of the liver who must have AST and ALT = 5 x
- •Other, protocol related inclusion criteria may apply.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •- Symptomatic brain metastases. Patients previously treated or
- •untreated for brain metastases that are asymptomatic in the absence of
- •corticosteroid therapy are allowed to enroll. Brain metastases must be
- •stable for at least 2 weeks after
- •completion of the definitive therapy with verification by imaging (e.g.
- •brain MRI completed at screening
- •demonstrating no current evidence of progressive brain metastases).
- •- Impaired cardiac function or clinically significant cardiac diseases,
- •including any of the following:
- •a. Left ventricular ejection fraction (LVEF) < 50% as
- •determined by multiple gated acquisition scan (MUGA) or
- •echocardiogram (ECHO)
- •b. Congenital long QT syndrome or family history of unexpected sudden
- •cardiac death
- •c. QTc corrected with Frederica's or Bazett's formula (QTcF) >450 ms for
- •males and >470 ms for females on screening ECG
- •d. Any other clinically significant heart disease such as angina pectoris,
- •resting bradycardia, left bundle branch block, ventricular
- •tachyarrhythmia, unstable atrial fibrillation, branch block or hemi block,
- •acute myocardial infarction or any heart disease that requires the use of
- •a cardiac pacemaker or implantable cardioverter defibrillator
- •- Patients who are currently receiving treatment with agents that are
- •known to cause QTc prolongation in humans.
- •- Patients who are currently receiving treatment with agents that are
- •metabolized predominantly through CYP3A4 and that have a narrow
- •therapeutic window.
- •- Patients with concurrent severe and/or uncontrolled concurrent
- •medical conditions that could compromise participation in the study
- •uncontrolled hypertension and/or diabetes mellitus, clinically significant
- •pulmonary disease, clinically significant neurological disorder, active or
- •uncontrolled infection)
- •- Current evidence of retinal disease; history of CSR, RVO or
- •ophthalmology as assessed by ophthalmologic examination at baseline
- •that would be considered a risk factor for CSR/RVO (e.g., optic disc
- •cupping, visual field defects, IOP > 21 mm Hg)
- •Other, protocol related exclusion criteria may apply.
研究者
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