EUCTR2013-005540-28-IT进行中（未招募）不适用
A phase Ib/II, multicenter study of LJM716 in combination with cetuximab in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
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
- •? Maximum of 1 prior therapy for recurrent or metastatic disease (Phase II)
- •? Most recent regimen contains both platinum and cetuximab (Phase II, group B).
- •? ECOG Performance Status (PS) = 2.
- •? Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade = 1, except for alopecia.
- •? Measurable disease as determined by RECIST v1.1.
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •? Previous anti-HER3 antibody treatment.
- •? Symptomatic brain metastasis.
- •? Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
- •? Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
- •? Inadequate end organ function.
- •? Ongoing diarrhea CTCAE Grade = 2.
研究者
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