EUCTR2012-004104-35-DE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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
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 - 1
- •- 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 10E9/L
- •Hemoglobin (Hgb) = 9 g/dL
- •Platelets = 75 x 10E9/L without transfusions within 21 days before 1st
- •PT/INR and aPTT = 1.5 ULN.
- •b. Serum creatinine =1.5 ULN
- •c. Hepatic function:
- •Serum total bilirubin = 1.5 x upper limit of normal (ULN)
- •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
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •-Presence of any brain metastases detected by MRI or CT with i.v.
- •contrast of the brain at screening.
- •- Uncontrolled arterial hypertension despite medical treatment
- •- 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. Angina pectoris = 3 months prior to starting study drug, acute
- •myocardial infarction
- •= 3 months prior to starting study drug, clinically significant resting
- •bradycardia, history or presence of ventricular tachyarrhythmia,
- •unstable atrial fibrillation (ventricular response >100 bpm),
- •complete left bundle branch block, right bundle, branch block and left
- •anterior hemi block bifascicular block), obligate use of a cardiac
- •pacemaker or implantable cardioverter defibrillator and any other
- •clinically significant heart disease.
- •- Patients who are currently receiving treatment with agents that are
- •metabolized predominantly through CYP3A4 and that have a narrow
- •therapeutic window. Agents that are known strong inducers or inhibitors
- •prohibited.
- •- Patients with concurrent severe and/or uncontrolled concurrent
- •medical conditions that could compromise participation in the study
- •uncontrolled diabetes mellitus, clinically significant pulmonary disease,
- •clinically significant neurological disorder, active or uncontrolled
- •- History or current evidence of retinal vein occlusion RVO) or curent
- •risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension,
- •hyperviscosity or hypercoagulability syndromes)
- •Other, protocol related exclusion criteria may apply.
研究者
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