NL-OMON53071已完成3 期
A 2-part phase III randomized, open label, multicenter study of LGX818 plus MEK162 versus vemurafenib and LGX818 monotherapy in patients with unresectable or metastatic BRAF V600 mutant melanoma - COLUMBUS
Array Biopharma Inc. (a wholly owned subsidiary of Pfizer Inc.)0 个研究点目标入组 50 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
- 50
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 64（—）
入选标准
- •1. Male or female patient, age >= 18 years;
- •2. Histologically confirmed diagnosis of locally advanced, unresectable or
- •metastatic cutaneous melanoma or unknown primary melanoma AJCC Stage IIIB, IIIC
- •3. Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to
- •enrollment, as determined by a sponsor designated central laboratory(ies);
- •4. Naïve untreated patients or patients who have progressed on or after prior
- •first-line immunotherapy for unresectable locally advanced or metastatic
- •melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any
- •other immunotherapy, radiotherapy, chemotherapy), except the administration of
- •BRAF or MEK inhibitors.
- •5. Evidence of at least one measurable lesion as detected by radiological or
- •photographic methods , 6. ECOG performance status of 0 or 1
- •7. Adequate bone marrow, organ function and laboratory parameters:
- •7.1. Absolute neutrophil count (ANC) >= 1.5 x 109/L,
- •7.2. Hemoglobin (Hgb) >= 9 g/dL without transfusions,
- •7.3. Platelets (PLT) >= 100 x 109/L without transfusions,
- •7.4. AST and/or ALT <= 2.5 × upper limit of normal (ULN); patient with liver
- •metastases <= 5 ×ULN,
- •7.5. Total bilirubin <= 2 × ULN,
- •7.6. Creatinine <= 1.5 mg/dL, or calculated creatinine clearance (determined as
- •per Cockcroft-Gault) >= 50mL/min;
- •8. Adequate cardiac function:
- •8.1. left ventricular ejection fraction (LVEF) >= 50% as determined by a
- •multigated acquisition (MUGA) scan or echocardiogram,
- •8.2. QTc interval <= 480 ms;
- •9. Negative serum β HCG test
排除标准
- •1. Any untreated central nervous system (CNS) lesion. However, patient treated
- •with radiotherapy or surgery are eligible if patient remained without evidence
- •of CNS disease progression >= 4 weeks. Patients must be off corticosteroid
- •therapy for >= 3 weeks.
- •2. Uveal and mucosal melanoma
- •3. History of leptomeningeal metastases;
- •4. History or current evidence of retinal vein occlusion or current risk
- •factors for RVO, 6. History of allogeneic bone marrow transplantation or organ
- •transplantation;
- •7. Previous or concurrent malignancy with the following exceptions:
- •adequately treated basal cell or squamous cell carcinoma of the skin
- •in situ carcinoma of the cervix, treated curatively and without evidence of
- •recurrence for at least 3 years prior to the study,
- •or other solid tumor treated curatively, and without evidence of recurrence
- •for at least 3 years prior to study entry;
- •8. Any previous systemic chemotherapy treatment, extensive radiotherapy or
- •investigational agent other than immunotherapy, or patients who have
- •received more than one line of immunotherapy for locally advanced
- •unresectable or metastatic melanoma., 9. Impaired cardiovascular function or
- •clinically significant cardiovascular diseases
- •10. Uncontrolled arterial hypertension despite medical treatment;
- •11. Known positive serology for HIV, active hepatitis B, and/or active
- •hepatitis C infection;
- •12. Patients who have neuromuscular disorders that are associated with elevated
- •13. Impairment of gastrointestinal function or gastrointestinal disease
- •14. Pregnant or nursing (lactating) women
- •15. Women of child-bearing potential, unless they are using highly effective
- •methods of contraception throughout the study and for 8 weeks after study drug
- •discontinuation.
- •16. Sexually active males unless they use a condom during intercourse while
- •taking the drug and for 8 weeks after stopping treatment
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