EUCTR2011-005875-17-BE进行中（未招募）1 期
A Phase Ib/II, multicenter, open-label, dose escalation study of LGX818 in combination with MEK162 in adult patients with BRAF V600 - dependent advanced solid tumors
Array BioPharma Inc. (a wholly owned subsidiary of Pfizer Inc)0 个研究点目标入组 179 人开始时间: 2013年10月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 179
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
- •Age = 18 years for both phases and arms
- •Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or confirmed diagnosis of non-resectable advanced metastatic colorectal cancer (mCRC), or any other indication upon agreement with the Sponsor, whose disease has progressed despite previous antineoplastic therapy or for whom no further effective standard therapy is available.
- •Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
- •Evidence of measurable disease as determined by RECIST v1.1.
- •World Health Organization (WHO) Performance Status = 2.
- •Negative serum pregnancy test within 72 hours prior to the first study
- •dose in all women of childbearing potential.
- •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 161
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Progressive disease following prior treatment with RAF-inhibitors in
- •combination with MEK-inhibitors.
- •Symptomatic or untreated leptomeningeal disease.
- •Symptomatic brain metastases. Patients are not permitted to receive
- •enzyme inducing anti-epileptic drugs. For the triple combination :
- •patients presenting any brain metastases are excluded.
- •Known acute or chronic pancreatitis.
- •History or current evidence of retinal disease, retinal vein occlusion or
- •ophthalmopathy.
- •Clinically significant cardiac disease.
- •Patients with abnormal laboratory values at Screening/baseline. For
- •the triple combination : patients with abnormal coagulation evaluations
- •(PT/INR >1.5 x ULN or aPTT >1.5 x ULN) are excluded.
- •Impairment of gastrointestinal (GI) function or GI disease that may
- •significantly alter the absorption of oral LGX818/MEK162
- •Previous or concurrent malignancy.
- •Pregnant or nursing (lactating) women.
- •For addition of LEE011 in the triple combination, congenital long QT
- •syndrome or family history of unexpected sudden cardiac death and/or
- •hypokalemia CTCAE Grade = 3.
- •Other protocol-defined exclusion criteria may apply.
研究者
相似试验
进行中（未招募）
不适用
A Phase Ib/II study of LGX818 in combination with MEK162 in adult patients with BRAF dependent advanced solid tumorsEUCTR2011-005875-17-FRovartis Pharma Services AG127
进行中（未招募）
不适用
A Phase Ib/II study of LGX818 in combination with MEK162 in adult patients with BRAF dependent advanced solid tumorsEUCTR2011-005875-17-ITovartis Farma S.p.A.127
进行中（未招募）
1 期
A Phase Ib/II study of LGX818 in combination with MEK162 in adult patients with BRAF dependent advanced solid tumorsEUCTR2011-005875-17-ESArray Biopharma Inc179
进行中（未招募）
1 期
Study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in BRAF mutant metastatic colorectal cancerBRAF mutant metastatic colorectal cancerMedDRA version: 18.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-002138-35-BEArray BioPharma Inc.162
进行中（未招募）
1 期
Study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in BRAF mutant metastatic colorectal cancerEUCTR2012-002138-35-ESArray BioPharma Inc.162