NL-OMON47322已完成2 期
A Phase II, open-label study to assess the safety and efficacy of oral MEK162 in adults with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600 or NRAS mutations - Phase II study of MEK162 for melanoma harboring BRAFV600 of NRAS mutations
Array Biopharma0 个研究点目标入组 31 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
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 or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery
- •3. Must have documented presence of somatic BRAFV600 or NRAS mutation in tumor tissue
- •4. All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable central confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol
- •5. Evidence of measurable tumor disease as per RECIST
- •6. WHO performance status of 0-2
- •7. Adequate organ function and laboratory parameters:
- •ANC >= 1.5 x 109/L
- •Hemoglobin (Hgb) >= 10 g/dL
- •Platelets (PLT) >= 75 x 109/L
- •AST and/or ALT <= 2.5 × upper limit of normal (ULN); patients with liver metastases <= 5 ×ULN
- •Bilirubin <= 2 × ULN
- •Calculated or directly measured creatinine clearance >= 60 mL/min/1.73m2
- •8. LVEF >= 50% as determined by MUGA scan or TTE
排除标准
- •1. History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or ophthalmopathy visible at screening that would be considered a risk factor for CSR or RVO
- •2. Patients with symptomatic CNS metastasis.
- •3. Prior therapy with a MEK- inhibitor
- •4. Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- •History/evidence of acute coronary syndromes (including MI, unstable angina, CABG, coronary angioplasty, or stenting) <6 months prior to screening
- •Symptomatic CHF, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality
- •Uncontrolled arterial hypertension, defined as BP > 140/100 mmHg
- •5. Known positive serology for HIV, active Hepatitis B, and/or active Hepatitis C infection
- •6. Any other condition that would, in the Investigator*s judgment, contraindicate patient*s participation in the clinical study due to safety concerns or compliance with clinical study procedures , e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
- •7. Patients who have received prior systemic anti-cancer treatment within the following time frames:
- •Patients who have received cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C) prior to starting study drugs
- •Patients who have received biologic therapy (e.g., antibodies) within 4 weeks prior to starting study drug
- •Patients who have been treated with continuous or intermittent small molecule therapeutics within <= 5 t1/2 of the agent, or <= 4 weeks prior to starting study drug where half life is unknown
- •Patients who have received any other investigational agents within a period of time that is less than the cycle length used for that treatment or <= 4 weeks (whichever is shorter) prior to starting study drugs
- •Treatment with prior radiotherapy within 28 days of the first dose of study drug; however, if the radiation portal covered <= 10% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy
- •8.Patients who have undergone major surgery <= 4 weeks prior to starting study drug or who have not recovered from side effects of such procedure
- •9.Pregnant or nursing (lactating) women.
- •10.Women may not become pregnant. Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation
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