EUCTR2013-001176-38-HU进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
入选标准
- •Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma (AJCC Stage IIIB, IIIC, or IV)
- •Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to randomization
- •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 or radiotherapy), except the administration of BRAF or MEK inhibitors.
- •Evidence of at least one measurable lesion as detected by radiological or photographic methods
- •ECOG performance status of 0 or 1
- •Adequate bone marrow, organ function, cardiac and laboratory parameters
- •Normal functioning of daily living activities
- •Other protocol-defined inclusion criteria may apply
- •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 675
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •Any untreated central nervous system (CNS lesion)
- •Mucosal or uveal melanoma
- •History of leptomeningeal metastases
- •History of or current evidence of retinal vein occlusion (RVO) or
- •current risk factors for RVO (e.g uncontrolled glaucoma or ocular
- •hypertension, history of
- •hyperviscosity or hypercoagulability syndromes);
- •Patients with washout period <6 weeks from the last dose of
- •ipilimumab or other immunotherapy.
- •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.
- •History of Gilbert's syndrome
- •Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
- •Impaired cardiovascular function or clinically significant cardiovascular
- •Uncontrolled arterial hypertension despite medical treatment
- •HIV positive or active Hepatitis B, and/or active Hepatitis C
- •Impairment of gastrointestinal function
- •Patients with neuromuscular disorders that are associated with
- •elevated CK.
- •Pregnant or nursing (lactating) women
- •Patients taking non-topical medication known to be a strong inhibitor
- •Medical, psychiatric, cognitive or other conditions that may
- •compromise the patient's ability to understand the patient information,
- •give informed consent, comply with the study protocol or complete the
- •Other protocol-defined exclusion criteria may apply
研究者
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