NL-OMON47339已完成3 期
The NEMO trial (NRAS melanoma and MEK inhibitor): A randomized Phase III, open label, multicenter, two-arm study comparing the efficacy of MEK162 versus dacarbazine in patients with advanced unresectable or metastatic NRAS mutation-positive melanoma - NEMO: NRAS melanoma and MEK inhibitor
Array Biopharma0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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 Male or female patients, age * 18 years
- •2 Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous or unknown primary melanoma AJCC Stage IIIC or IV (Uveal and mucosal melanoma are excluded)
- •3 Presence of NRAS Q61 mutation in tumor tissue prior to randomization, as determined by a central laboratory
- •4 Naïve untreated patients or patients who have progressed on or after prior treatment with any number of lines of immunotherapy for unresectable or metastatic melanoma;
- •5 Evidence of at least one measurable lesion as documented by radiological or photographic methods according to RECIST (version 1.1)
- •6 ECOG performance status of 0-1
- •7 Adequate bone marrow and organ function and laboratory parameters:
- •* ANC * 1.5 x 109/L
- •* Hemoglobin (Hgb) * 9 g/dL without transfusions
- •* Platelets (PLT) * 100 x 109/L without transfusions
- •* AST and/or ALT * 2.5 × upper limit of normal (ULN); patients with liver metastases * 5 ×ULN
- •* Total bilirubin * 2 × ULN
- •* Creatinine * 1.5 mg/dL
- •8 Adequate cardiac function:
- •* left ventricular ejection fraction (LVEF) * 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram
- •* QTc interval * 480 ms
- •9 Negative serum * HCG test (female patients of childbearing potential only) performed locally within 72 hrs prior to first dose
排除标准
- •1 Any active central nervous system (CNS) lesion (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with radiotherapy or surgery are eligible if the patient remained without evidence of CNS disease progression * 3 months. Patients must be off corticosteroid therapy for * 3 weeks.
- •2 Uveal or mucosal melanoma
- •3 History of leptomeningeal metastases
- •4 History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or predisposing factors to RVO or CSR
- •5 History of allogeneic bone marrow transplantation or organ transplantation
- •6 History of Gilbert*s syndrome
- •7 Previous or concurrent malignancy with the following exceptions:
- •* adequately treated basal cell or squamous cell carcinoma
- •* in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to the study
- •* a primary malignancy which has been completely resected and in complete remission for *5 years
- •8 Prior therapy with a MEK inhibitor
- •9 Patients with washout period < 12 weeks from the last dose of ipilimumab or other immunotherapy;
- •10 Impaired cardiovascular function or clinically significant cardiovascular diseases
- •11 Uncontrolled arterial hypertension, despite medicial treatment
- •12 Known positive serology for HIV, active Hepatitis B, and/or active Hepatitis C infection
- •13 Patients who have neuromuscular disorders that are associated with elevated CK
- •14 Impairment of gastrointestinal function or gastrointestinal disease
- •15 Pregnant or nursing (lactating) women
- •16 Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 8 weeks after stopping study treatment.
- •17 Sexually active males, unless they use a condom during intercourse while taking drug and for 8 weeks after stopping study medication.
研究者
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