EUCTR2012-003008-11-SE进行中（未招募）1 期
A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATEDBRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA
F. Hoffman-La Roche Ltd.0 个研究点目标入组 495 人开始时间: 2012年12月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 495
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
- 性别
- All
入选标准
- •= 18 years of age
- •Stage IIIc or Stage IV melanoma harboring BRAF V600 mutation
- •BRAF V600 mutation must be confirmed by cobas 4800 BRAF V600 mutation test
- •Measurable disease according to RECIST 1.1
- •Women of childbearing potential with negative serum pregnancy test prior to randomization
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Adequate baseline organ function
- •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 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Any prior use of a BRAF or MEK inhibitor
- •Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed
- •History of another malignancy except subjects who have been disease free for 3 years or have completely resected non-melanoma skin cancer.
- •Patients with active CNS lesions (including carcinomatous meningitis) are excluded. However, patients are eligible if:
- •a)all known CNS lesions have been treated with stereotactic therapy or surgery, AND
- •b)no evidence of clinical and radiographic disease progression in the CNS for = 3 weeks after radiotherapy or surgery.
- •Whole brain radiotherapy is not allowed with the exception of patients who have had definitive resection or stereotactic therapy of all radiologically detectable parenchymal brain lesions.
- •Evidence of cardiovascular risk (LVEF < LLN; QTc = 450 msec; blood pressure =140/90 mmHg which cannot be controlled by anti-hypertensive therapy)
- •History, risk factors for or evidence of neurosensory retinal detachment, retinal vein occlusion or neovascular macular degeneration.
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