NL-OMON44775已完成不适用
A phase Ib/II, multicenter, open label, study of LEE011 in combination with MEK162 in adult patients with NRAS mutant melanoma - LEE011 with MEK162 in NRAS mutant melanoma (CMEK162X2114)
Array Biopharma0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NRAS mutant melanoma (written documentation)
- •2. ECOG performance status of 0 * 1.
- •3. Phase Ib: evaluable disease only is allowed. For phase II expansion at least one measurable lesion as defined by RECIST 1.1.
- •4. Archival of fresh tumor biopsy specimen (if no archival tumor) for all patients.
- •5. A tumor biopsy at time of study entry and on day C1D15 in the phase II part of the study.
- •6. A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy
- •and the first dose of study drugs:
- •* > 2 weeks for systemic antineoplastic therapy or any experimental therapy
- •* > 6 weeks for nitrosoureas and mitomycin-C).
- •* * 4 weeks for biologic therapy (e.g., antibodies)
- •7. Laboratory values:
- •a. Absolute Neutrophil Count (ANC) * 1.5 x 109/L.
- •b. Hemoglobin (Hgb) * 9 g/dL (5,58 mmol/L)
- •c. Platelets * 75 x 109/L without tranfusions within 21 days before 1st treatment.
- •d. PT/INR and aPTT * 1.5 ULN
- •e. Serum creatinine *1.5 ULN.
- •f. Serum total bilirubin * 1.5 x upper limit of normal (ULN).
- •g. AST and ALT * 3 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT * 5 x ULN.
- •8. A negative serum pregnancy test * 72 hours before starting study treatment
排除标准
- •1. Presence of any brain metastases detected by MRI or CT of the brain at screening.
- •2. Uncontrolled arterial hypertension despite medical treatment
- •3. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the
- •absorption of LEE011 or MEK162.
- •4. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •* Left ventricular ejection fraction (LVEF) * 50%
- •* Congenital long QT syndrome or family history of unexpected sudden cardiac death,
- •* QTcF or QTcB >450 ms for males and >470 ms for females at screening,
- •* Angina pectoris or acute myocardial infarction * 3 months prior to starting study drug, clinically significant bradycardia, history or presence of ventricular tachyarrhytmia, unstable atrial fibrillation, complete left bundle branch block, obligate use of pacemaker or implantable cardioverter defibrillator
- •5. Treatment with agents that are known to cause QTc prolongation.
- •6. Treatment with agents that are metabolized predominantly through CYP3A4 and that have a narrow therapeutic window. Agents that are known strong inducers or inhibitors CYP3A4 are prohibited. Enzyme inducing anti-epileptic drugs are not permitted.
- •7. Patients with concurrent severe and/or uncontrolled concurrent medical conditions
- •8. Major surgery <2 weeks before starting study treatment.
- •9. Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C
- •10. 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.
- •11. Pregnant or nursing (lactating) women.
研究者
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